major safety alerts in september 2012 - mdco.gov.hk · description of product source of...

Date of Issue

(YYYY/MM/DD)Description of Product

Source of

Information*Reference No. by Source

Alert Type by

SourceLocal Agent

2012/09/04

Medtronic, Inc The Screw Module (―Screw Caddy‖) used with the ATLANTIS®

Anterior Cervical Plate System and the Premier Anterior Cervical Plate System

Part no.: 176-504, 176-503, and 1860503

MHRA 2012/008/029/081/023 FSNMedtronic International

Ltd

2012/09/04Micro-Tech Europe Micro-Tech oesophagus stent with the REF ST01-

156.xx.xxxMHRA 2012/008/017/081/014 FSN N.A.

2012/09/04Applied Medical Resources Corporation Vascular Catheters [Model no.: a)

A44XX, b) A47XX, c) A4FXX d) IRR-XXX-XX]MHRA 2012/008/030/081/010 FSN

Long Hin Medical

Limited/ Olympus Hong

Kong and China Limited

2012/09/04Ferrosan Medical Devices A/S a) SURGIFLO Haemostatic Matrix Kit; b)

SURGIFLO Haemostatic Matrix Kit with Thrombin [Product code.: MS-0010 & MHRA 2012/008/024/291/005 FSN

Johnson & Johnson

(Hong Kong) Ltd.

2012/09/04Hospira Inc. Latex-Free Extension Set with Locking Luer ―T‖[List no.:

0F8989701; Lot no.: 12-030-NY]MHRA 2012/008/030/081/020 FSN Hospira Limited

2012/09/04Siemens Healthcare Diagnostics Dimension ® Hemoglobin A1c (HB1C) Flex ®

Reagent cartridges (Catalogue no.: DF105A)MHRA 2012/008/030/081/020 FSN

Siemens Healthcare

Diagnostic Limited

2012/09/04Volcano Corporations Volcano s5/s5i1111 Family, Software Version 3.2.1 I

3.2.2MHRA 2012/008/030/081/020 FSN Prism VCN Limited

2012/09/05 Roche Diagnostics Co2-For Cobas C701/702 Analyzer Health Canada 76803 Type IIIRoche Diagnostics

(Hong Kong) Ltd

2012/09/05 Steris Reliance 130 and 130L Cart Washer Health Canada 76135 Type IIISwedish Trading Co.

Ltd.

2012/09/05Model no.: ART0422

Health Canada 76745 Type IIISenrex International

Ltd.

2012/09/05

Baxter Healthcare Corp INTERLINK System BURETROL Solution Set with

150mL Burette

(Ball-Valve Drip Chamber) and CLEARLINK System BURETROL Solution Set

with 150mL CLEARLINK Burette (Ball-Valve Drip Chamber)

Product code no.: 2C7519 and 2C8819

Baxter

Healthcare

Limited

FCA-2012-070 NA Baxter Healthcare Ltd

2012/09/05

Terumo Cardiovascular Systems Corporation A) CDI Blood Parameter

Monitoring System 500; B) CDI System 100 Hematocrit/Saturation Monitoring

System; C) CDI 101 Blood HCT/Oxygenation Monitor

Health Canada 76881 Type IITERUMO CHINA (H.K.)

LTD.

2012/09/05Philips Medical Systems DMC GMBH DigitalDiagnost [Model no.: 9890-010-

8390X; Lot no.: 496371; Serial no. 12000057]Health Canada 77039 Type III

Philips Electronic Hong

Kong Ltd

2012/09/05 Vital Images Inc Vitrea Software Application Health Canada 77138 Type II N.A.

2012/09/05 Wallac OY DELFIA Inducer, Model.: 3027-0010, Lot no.: 615442, 615809 Health Canada 76876 Type II N.A.

2012/09/05Integra Burlington MA Inc A) CRW System - Intubation Head Ring Kit; B) CRW

System - Lightweight ArcHealth Canada 77069 Type II N.A.

2012/09/07

Advanced Sterilization Products CIDEX OPA, High Level Disinfectant Solution,

Glutaraldehyde-free (0.55% ortho-phthaladehyde) solution. [product codes:

20390 20391 20394 and 20690]

FDA Z-2276-2012 Class IIJohnson & Johnson

(Hong Kong) Ltd.

2012/09/10 Boston Scientific Z Flex-270 Steerable SheathBoston Scientific

(Hong Kong) LtdNA NA

Boston Scientific (Hong

Kong Ltd)

2012/09/11Horiba Medical ABX Pentra ML (Versions V8.0.x and below, and Versions

V9.0.1 and V9.0.2)MHRA 2012/008/031/081/017 FSN N.A.

2012/09/11

Hospira Inc. Drum Cartridge and Venocath Catheters (List no.: 0G892 (Drum

Cartridge Catheter), 0G891 (Drum Cartridge Catheter), 04614 (Venocath 14G),

04816 (Venocath 16G), 04718 (Venocath 18G Abbocath T); lot no.: all)

MHRA 2012/009/003/081/034 FSN Hospira Limited

2012/09/11 Hospira Inc. LifeCare PCA infusion system (List no.: 0F782) MHRA 2012/008/031/291/001 FSN Hospira Limited

Major Safety Alerts in September 2012

*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom;

Health Canada = Health Canada, Canada

http://www.mhra.gov.uk/home/groups/fsn/documents/fieldsafetynotice/con183915.pdf







http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_july-sept_2012-eng.php


http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_drugs-med_july-sept_2012-eng.php






http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2276-2012&w=09052012&lang=eng




2012/09/11 Bayer HealthCare GLUCOFACTS Deluxe software version 3.01 MHRA 2012/009/005/601/002 FSN Bayer HealthCare Ltd

2012/09/11 Valisafe International Valisafe Bowie & Dick Type Test MHRA 2010/008/010/401/002 FSN N.A.

2012/09/11 Thermo Fisher Scientific Remel Xpect® Clostridium difficile Toxin A/B MHRA 2012/008/031/601/003 FSNThermo Fisher

Scientific (HK)

2012/09/11Systagenix Wound Management INADINE® PVP-I Non Adherent Dressing

(Model no.: P01491 (9.5cm x 9.5cm))MHRA 2012/008/031/291/004 FSN

United Italian Corp.

(HK) Ltd

2012/09/11 Stryker Orthopeadics 6.5mm Cancellous Bone Screw 25mm and 35mm MHRA 2012/008/031/081/018 FSN Stryker China Ltd

2012/09/11

Siemens Diagnostics BR Assay Calibration, CA 27.29, Ref 03896216 and

02419937 and CA 15-3, Ref 01157807 and 03204829, in ADVIA Centaur,

ADVIA Centaur XP and ADVIA Centaur CP systems

MHRA 2012/008/031/601/005 FSNSiemens Healthcare

Diagnostic Limited

2012/09/11

GE Healthcare Invasive Blood Pressure Cable__Production ID no.: a) 2016995-

001, b) 2016995-002, c) 2016995-003__respective lot code: a) xxxx2010E, b)

xxxx2010D, c) xxxx2010C

MHRA 2012/009/003/081/001 FSNGE Medical Systems

Hong Kong Ltd.

2012/09/11 Lima Orthopaedics UK Limited Lima SMR Anatomical Polythylene Liner MHRA 2012/008/020/081/008 FSN N.A.

2012/09/11

PARI GmbH Power Adapter manufactured by FRIWO used in PARI SOLE N

Inhalation Device

Model number DT50, Type FW7405M/22, Item number 025B0250

MHRA 2012/009/003/081/023 FSN N.A.

2012/09/11Siemens Healthcare Diagnostics, Inc Flex Large 4 Coil for MAGNETON Skyra,


Diagnostic Limited

2012/09/11

Siemens IIMMULITE 2000/IMMULITE 2000 XPi Troponin I Reagent Kit (Model

no.: L2KTI2 and Lot no.: 206 and above) MHRA 2012/009/006/601/007 FSNSiemens Healthcare

Diagnostic Limited

2012/09/11BrainLab M3 micro-MLC, including the permanently mounted micro-MLC used

in Novalis 600N LinacMHRA 2012/009/006/081/012 FSN BrainLAB Ltd

2012/09/11Fujifilm Medical Systems Wireless D-EVO with Automatic X-ray Detect (AXD)

software installedMHRA 2012/009/003/081/038 FSN N.A.

2012/09/11GCE Mediline O2/N2O DEMAND VALVES [Model no.: 9630320, 14090426,

14114033, K008212, MM3851, MM3863, MM3893, MM4095]MHRA 2012/008/023/601/004 FSN N.A.

2012/09/12 Silicone tracheostomy tubes MHRA MDA/2012/062 MDA N.A.

2012/09/13 Newport Medical Instruments Inc Newport HT70 and HT70 Plus Ventilators FDA Z-2250-2012 Class I N.A.

2012/09/13Siemens Healthcare Diagnostics, Inc Siemens ADVIA Centaur Multi-Diluent

1[Catalog. no.: 2 Pack REF 07907174 (110312) 6 Pack REF 07293184 FDA Z-2313-2012 Class II

Siemens Healthcare

Diagnostic Limited

2012/09/13

Capintec Inc. Capintec Captus 3000 Thyroid Uptake System [Catalog. no.: a)

New systems :5430-0076, 5430-0077, 5430-0103, and 5430-0087; b)

Conversion systems: 5430-0118 and 5430-0119]

FDA Z-2312-2012 Class II N.A.

2012/09/13

Terumo CVS Corporations Flow Module for Terumo Advanced Perfusion

System 1 [Catalog. no.: 802018; Serial no.: 00032, 00042, 00056, 00147,

00623, 00700-00764, 00766-00820, 00823-00847]

TERUMO

CHINA (H.K.)

LTD.

AA-2012-014-R NATERUMO CHINA (H.K.)

LTD.

2012/09/18Beckman Coulter Inc. Unicel DXH 800 Coulter Cellular Analysis System

(Model/Part no.: 629029)Health Canada 77182 Type III

Beckman Coulter Hong

Kong Ltd

2012/09/18 Vital Signs Colorado Inc. General Purpose Temperature Probe Health Canada 76750 Type II N.A.

2012/09/18

GE Medical Systems Information Technologies, Inc. A) Dash 3000 Patient

Monitor, B) Dash 5000 Patient Monitor, C) Dash 4000 Patient Monitor

XXXX,C) DASH4-XXXX-XXXX-XXXX

Health Canada 75336 Type IIGE Medical Systems

Hong Kong Ltd.

2012/09/18Elekta Business Area Software Systems, Impac Medical Systems Inc

Sequencer (Versions: MOSAIQ 1.60V1 to 2.30.01)Health Canada 74887 Type II Elekta Ltd

2012/09/18Instrumentation Laboratory Co A) ACL Top 500 CTS, B) ACL Top Base, Top

CTS, Top 700 LAS, C) ACL Top 700, D) ACL Top 700 CTSHealth Canada 77286 Type III


Kong Ltd

2012/09/18Beckman Coulter Inc. UniCel DXH 800 Coulter Cellular Analysis System, PN

629029Health Canada 77181 Type III


Kong Ltd















http://www.mhra.gov.uk/home/groups/dts-bs/documents/medicaldevicealert/con184714.pdf










2012/09/18Beckman Coulter Inc. UniCel DXH 800 Coulter Cellular Analysis System, PN

629029Health Canada 77180 Type III


Kong Ltd

2012/09/18 Carefusion 303, Inc. Alaris PC Unit Model 8000 [Catalogue no.: 8000APM] Health Canada 56581 Type ICareFusion Hong Kong

Ltd.

2012/09/18

Terumo Cardiovascular Systems Corp. A) Advanced Perfusion System 1 -

Electronic Gas Blender/Analyzer; B) Advanced Perfusion System 1 - Base Unit

[control knobs adjustments]

Health Canada 76898 Type IITERUMO CHINA (H.K.)

LTD.

2012/09/18C-K Dental Ind. Co. Ltd. Disposable Dental Needles [Catalogue no..: 27g x

30mm (0.4 x 30mm); 30g x 21mm (0.3 x 21mm); Lot no.: 110910]Health Canada 76986 Type II C-K Dental Ind. Co. Ltd.

2012/09/18Philips Medical Systems Suresigns VS2+ Vital Signs Monitor [Catalogue no..:

863278, 863279]Health Canada 77177 Type II


Kong Ltd

2012/09/18 3M Healthcare 3M Optreoz Sterilizer (Model/Catalog no.: 125-Z) Health Canada 77327 Type III 3M Hong Kong Ltd

2012/09/18Ameriwater MRO Dialysis RO+ System (Model/Catalog no.: '00MRO120,

'00MRO121, '00MROS20, '00MROS21, MRO1, MROS; serial no.: 31000 - Health Canada 77324 Type III N.A.

2012/09/18Ormco Corporation AEZ Mini Distal Cutter (Model/Catalog no.: 803-0500; Lot

no.: 11M35M)Health Canada 77378 Type III

Young's L&S Dental

Supplies Ltd--Hong

2012/09/18PDG Product Design Group Inc. Fuze (Model/Catalog no.: Fuze 20, Fuze 50;

Lot no.: 52651 to 52919)Health Canada 77473 Type III N.A.

2012/09/18Boston Scientific LeVeen Standard Needle Electrode System and LeVeen

CoAccess Needle Electrode System

Boston Scientific

(Hong Kong) Ltd90793918-FA NA

Boston Scientific (Hong

Kong Ltd)

2012/09/18Philips Gemini System-2 Slice (Model no.: 45356 790 0891, Serial no: 103,

115, 144)Health Canada 77328 Type II


Kong Ltd

2012/09/18

Carestream Inc A) DRX-Evolution / Premium OTC FF Wallstand; B) DRX-

Evolution / Premium OTC FF Table; C) DRX-Evolution / Motorized OTC FF

Wall; D) DRX-Evolution / with Motor, Fixed Wall

Health Canada 77179 Type II N.A.

2012/09/18Smith and Nephew Inc High Offset Neutral Modular Neck (Model no.:

71352112, Lot no.: 12FTM0019A, 12FTM0019D, 12FTM0021B)Health Canada 77326 Type II Smith & Nephew Ltd.

2012/09/18 Capsule Technology Capsule Neuron Docking Station, Model no.: DC-NU-DS Health Canada 77095 Type II N.A.

2012/09/19Sorin Sorin S5/C5 Perfusion System (Model no.: 10-80-00, 10-85-00, 10-88-60,

10-88-00, 58-00-00)MHRA 2012/009/011/081/023 FSN IntegMed Limited

2012/09/19 Spacelabs Healthcare Spacelabs Healthcare Integrated Module Housing MHRA 2012/009/007/081/026 FSNSchmidt Bio Med Tech

(H.K.)

2012/09/19Thermo Fisher Scientific Oxoid Ready Poured Plate Brilliance MRSA 2 Agar,

PO1210A, Lot Number 1226295MHRA 2012/009/011/601/007 FSN

Thermo Fisher

Scientific (HK)

2012/09/19 OriGen Biomedical AB OriGen Syringe DMSO MHRA 2012/008/023/291/034 FSN N.A.

2012/09/19 Philips Healthcare Brilliance CT 6, 16, MX8000 v. EXP and GEMINI Dual MHRA 2012/009/007/081/002 FSNPhilips Electronic Hong

Kong Ltd

2012/09/19 Philips Healthcare SureSigns VSi/VS2 Patient Monitors MHRA 2012/009/010/081/032 FSNPhilips Electronic Hong

Kong Ltd

2012/09/19Siemens Healthcare Diagnostics Inc. MMULITE 2000/IMMULITE 2000 XPi EBV-

EBNA IgG (Part no.: L2KEB2 and Lot no 215 and aboveMHRA 2012/009/007/601/001 FSN

Siemens Healthcare

Diagnostic Limited

2012/09/19Bausch & Lomb Posterior Fluidics Module (PFM), Stellaris PC Vision

Enhancement SystemMHRA 2012/009/007/081/006 FSN

Bausch & Lomb (Hong

Kong) Ltd

2012/09/19JRI Orthopaedics Furlong HAC femoral stem 12mm 133° neck angle (Lot no.:

068548)MHRA 2012/008/023/291/004 FSN N.A.

2012/09/19Macopharma Whole Blood set (MacoPharma REF: 1201 123) (Model/Part no.:

FQE6280LB)MHRA 2012/009/007/081/007 FSN N.A.

2012/09/19

Cerus Corporation INTERCEPT Processing Sets for Plasma [Model no.:

INT3102B and INT3104B; Lot no: 12B29L61, 12C15L61, 12C29L61,

12D05L61, 12D12L61, and 12D19L61]

MHRA 2012/009/012/081/002 FSN N.A.

























2012/09/19

GE Healthcare GE Centricity RIS-i [Software Versions: 4.1.26, 4.2.3, 4.2.4,

4.2.5, 4.2.6, 4.2.7, 4.2.24, 4.2.25 and 4.2.26] MHRA 2012/009/012/081/009 FSNGE Medical Systems

Hong Kong Ltd.

2012/09/19

HeartSine Technologies HeartSine Samaritan PAD 300/PAD 300P AED [Serial

no.: 0400000501 to 0700032917; 08A00035000 to 10A0070753; 10C00200000

to 10C002108200]

MHRA 2012/009/011/081/001 FSN HTM Medico Pte Ltd

2012/09/21Steris Corporation The SYSTEM 1E Liquid Sterilant Processing System (Model

no.: P6500)美國FDA Z-2335-2012 第 II 級回收

Swedish Trading Co.

Ltd.

2012/09/21GE Healthcare LLC Optima XR220amx and Optima XR200amx. (Part no.:

5555000-3, 5555000-4, 5555000-5, 5555000-6)美國FDA Z-2255-2012 to Z-2256-2012 第 II 級回收

GE Medical Systems

Hong Kong Ltd.

2012/09/25 Doctors Research Group Kryptonite Bone Cement MHRA 2012/009/020/081/011 FSNTransmedic China

Limited

2012/09/25IND Diagnostic Inc Urinalysis Reagent Strip, Catalogue no.: Series 900 (All

parameter combinations from 900-01 to 900-11)MHRA 2012/008/015/401/002 FSN N.A.

2012/09/25MAQUET Cardiopulmonary AG All type of HLS Cannulae (PAS…, PAL…,

PVA…, PVL…)MHRA 2012/009/018/081/004 FSN

Shun On Healthcare

Limited/MAQUET Hong

Kong Limited

2012/09/25 Philips Healthcare Brilliance CT Big Bore with Software Versions 2.4.7 or 2.4.8 MHRA 2012/009/019/081/020 FSNPhilips Electronic Hong

Kong Ltd

2012/09/25 Pace Medical, Inc MICRO-PACE - 4580 MHRA 2012/009/019/081/021 FSN N.A.

2012/09/25 Simeon Medical Sim.LED 5000 and Sim.LED 7000 MHRA 2012/007/027/081/013 FSN N.A.

2012/09/25 Smith and Nephew Inc Birmingham Hip™ Modular HeadsSmith and

NephewNA

Smith and

NephewSmith & Nephew Ltd.

2012/09/25Rocket Medical Rocket® Pleuraseal 3 Chest Drainage Bottle (produced

between July 2012 and September 2012)MHRA 2012/009/017/601/001 FSN N.A.

2012/09/25Siemens AG MAVIG PORTEGRA 2 system (operated in conjunction with a

Siemens AX system)MHRA 2012/009/020/081/006 FSN

Siemens Healthcare

Diagnostic Limited

2012/09/26

Custom Medical Specialties Custom HSG Tray, Hysteroscopic Sterilization

Pack, Custom Vein Tray, Custom Amnio Tray, Fox Chase Specials Pack,

Abington Radiology Drainage Pack, Custom CT Biopsy Tray, HSG Tray,

Custom Myelogram Tray, and Hysteroscopy Sterile Procedure Kit

FDA NAMedWatch, MD

RecallN.A.

2012/09/26 Beckman Coulter UniCel DxH 800 Coulter Cellular Analysis System MHRA 2012/009/005/601/003 FSNBeckman Coulter Hong

Kong Ltd

2012/09/27 Mindray WATO EX-55 and WATO EX-65Mr Holdings

(HK) Ltd. NA NA Mr. Holdings (HK) Ltd

2012/09/28

Philips Brilliance CT 16 System (System code no.: 728246; Serial no.: 6462,

6447, 6495, 6514, 6467, 6482, 6473, 6544, 6439, 6453, 6436, 6536, 6448,

6449, 6471, 6498, 6502, 6504, 6452, 6510, 6508, 6438, 6513, 6456, 6505,

6457, 6442, 6454, 6461, 6469, 6485, 6458, 6475, 6487, 6531, 6520, 6490,

6470, 6437, 6497, 6481, 6489, 6488, 6455, 6543, 6499, 6493, 6443, 6463,

6476, 6477, 6478, 6526, 6545, 6546, 6518, 6491, 6450, 6451, 6468, 6464,

6466, 6459, 6472, 6444, 6445, 6529, 6530, 6440, 6532, 6515, 6486, 6507,

6512, 6483, 6524, 6480, 6479, 6509, 6460, 6441, 6465, 6474, 6484, 6492,

6503, 6511, 6517, 6519, 6523, 6525, 6549, 6555; Software version: 2.3.6)

FDA Z-2404-2012 Class IIIPhilips Electronic Hong

Kong Ltd




http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Event-Detail.cfm?action=detail&id=62946&w=09192012&lang=eng









(MedWatch) http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm269800.htm(MD Recall) http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm320774.htm



Date of Issue

(YYYY/MM/DD)Description of Product

Source of


Alert Type by

SourceLocal Agent

2012/08/02 Respironics Inc. (Philips). Respironics Trilogy 100, 200, and 202 Ventilators FDA Z2024-2012 Class I Celki Medical Company

2012/08/02GE Medical Systems OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus;

OEC 9800 MD Motorized C-arm SystemFDA Z-2038-2012 Class I

GE Medical Systems

Hong Kong Ltd.

2012/08/02 Carefusion Alaris PC Unit, Model 8015 FDA NAMedWatch, MD

recall

CareFusion Hong Kong

Ltd.

2012/08/06

Ethicon Endo-Surgery PROXIMATE® PPH Hemorrhoidal Circular Stapler and

Accessories 33mm (Product Code PPH03) and PROXIMATE® HCS

Hemorrhoidal Circular Stapler and Accessories 33mm (Product Code PPH01)

Johnson &

Johnson (Hong

Kong) Ltd.

7283 NAJohnson & Johnson

(Hong Kong) Ltd.

2012/08/06Philips Healthcare Philips EasyDiagnost (70642, 70643, 706030, 706031, and

706032)

Philips Electronic

Hong Kong Ltd70600068 NA


Kong Ltd

2012/08/07 Berlin Heart EXCOR arterial cannula with graft CGRG-021 MHRA 2012/007/030/081/003 FSN IntegMed Limited

2012/08/07 Depuy- a Johnson & Johnson company Orthopaedic Hip Retractors MHRA 2012/007/030/081/028 FSNJohnson & Johnson

Medical (HK)

2012/08/07Vascutek Ltd. Biplex vascular grafts and Biplex Biovalsalva Conduits (stentless

and stented)MHRA 2012/007/030/291/002 FSN

Keymax Technology

(HK) Ltd.

2012/08/07 Stryker Orthopeadics PAR Extension Piece MHRA 2012/008/001/291/010 FSN Stryker China Ltd

2012/08/07 Stryker Instruments Radiofrequency (RF) Cannulae MHRA 2012/007/023/081/004 FSN Stryker China Ltd

2012/08/07DePuy Synthes Spine EXPEDIUM Offset Torque Wrench [Catalog no.: 2797-29-

510]MHRA 2012/007/030/081/029 FSN

Johnson & Johnson

(Hong Kong) Ltd.

2012/08/07 GE Healthcare CARESCAPE Monitor B650 MHRA 2012/007/030/081/002 FSNGE Medical Systems

Hong Kong Ltd.

2012/08/07 GE Healthcare CARESCAPE Monitor B850 MHRA 2012/007/030/081/004 FSNGE Medical Systems

Hong Kong Ltd.

2012/08/07 GE Healthcare GE Centricity PACS-IW (Software Versions: 3.7.1 and later) MHRA 2012/008/001/291/008 FSNGE Medical Systems

Hong Kong Ltd.

2012/08/07Gerati GERATI Babcock Tissue Holding Forceps, 31cm (Affected lot no.:

091103, 091107, 061206)MHRA 2012/005/022/401/009 FSN N.A.

2012/08/07

Beckman Coulter Inc. IntraPrep Leucocytic Permeabilization Reagent

(Serial no.: A07803 and Lot no.: 38 with the expiration date 29/08/2013) MHRA 2012/008/001/601/001 FSNBeckman Coulter Hong

Kong Ltd

2012/08/07 Siemens Healthcare Diagnostics Syngo Imaging XS, Version VA70A or higher. MHRA 2012/008/001/291/013 FSNSiemens Healthcare

Diagnostic Limited

2012/08/07

Steris Washer / disinfector (endoscope disinfection unit) model HAMO PTX,

PTX+, UCX et UCX+

Version software version prior to 25.3

MHRA 2012/008/001/081/002 FSNSwedish Trading Co.

Ltd.

2012/08/07

Stryker Osteosynthesis Teflon Tube T2 Humerus, Sterile (Model: 18060073S

and lot number: K123596) MHRA 2012/007/030/081/009 FSN Stryker China Ltd

2012/08/08

Sysmex Corporation A) XE-5000 Hematology Analyzer, B) XE-2100

Hematology Analyzer, C) XE-2100C Hematology Analyzer

Model/Part no.: A) 063-7591-7, B) 983-1341-1, C) 053-2311-4

Health Canada 76146 Type III Sysmex Hong Kong Ltd.

2012/08/08Elekta Business Area Software Systems, Impac Medical Systems Inc

Sequencer (Versions: MOSAIQ 1.30, 1.60, 2.00, 2.10, 2.20)Health Canada 64245 Type III Elekta Ltd

2012/08/08 Biocare Medical Vina Green Chromagen Kit Health Canada 72974 Type IIIOracle Link Technology

Limited

Major Safety Alerts in August 2012



http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Event-Detail.cfm?action=detail&id=62393&w=08012012&


http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm314090.htm; http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm314019.htm


















2012/08/08PSC Industries Inc. DBA Olsen Medical Bayonet Forceps 8.5" Serrated 1.0 mm

Tips Electosurgical / Monopolar Forceps / ReuseableHealth Canada 75528 Type III N.A.

2012/08/08

Beckman Coulter Inc. A) UIBC Reagent (for Beckman Coulter AU5400

Immunochem System), B) UIBC Reagent (for Beckman Coulter AU2700

Immunochem System), C) UIBC Reagent (for Beckman Coulter AU

Immunochem System)

Health Canada 76208 Type IIIBeckman Coulter Hong

Kong Ltd

2012/08/08 Health Canada 76301 Type IIICiticon (Hong Kong)

Limited

2012/08/08

Beckman Coulter Inc. SYNCHRON Systems Compliment C4 ( Model no.:

988471 and Affected lot no.: M010418, M101905, M106012, M1009007,

M111007)Health Canada 76345 Type III


Kong Ltd

2012/08/08

3M Healthcare Steri-Drape 2 Incise Drape ( Product code.: 2050 & Batch no.:

2017-03 BF) Health Canada 76349 Type III 3M Hong Kong Ltd

2012/08/08 Health Canada 76350 Type IIISiemens Healthcare

Diagnostic Limited

2012/08/08

Siemens Medical Solutions USA, Inc Syngo Dynamics Server, Software

Health Canada 76351 Type IIISiemens Healthcare

Diagnostic Limited

2012/08/08

Siemens Medical Solutions USA, Inc Syngo Dynamics Server, Software


Diagnostic Limited

2012/08/08 Health Canada 76358 Type IIICiticon (Hong Kong)

Limited

2012/08/08Draeger Medical, Inc. Phototherapy Unit PT 4000 for Neonates / Infants

(Model/Part no.: 2M-21700)Health Canada 75530 Type II

Draeger Medical Hong

Kong Ltd.

2012/08/08 Biomatlante Eclipse Granules (model/part no: E1G010, lot no: 0309F112) Health Canada 75809 type III N.A.

2012/08/08

Beckman Coulter Inc. Coulter 6C Cell Control (Model/Part no.: 628027,

A59925; lot no.: 2879740K, 2879750K, 2882770K, 2882560K, 2882570K,

2885180K, 2888120K, 2888130K)

Health Canada 76041 type IIIBeckman Coulter Hong

Kong Ltd

2012/08/08Roche Diagnostics Online DAT Amphetamines II Cobas C501, C502, and

C311 (Model/Part no.: 4939425190, lot no.: 65282601)Health Canada 75990 Type III

Roche Diagnostics

(Hong Kong) Ltd

2012/08/08Siemens Healthcare Diagnostics Dimension Vista HCYS Flex Reagent Cart

(Model/Part no.: K7044; lot no.: 12062MA, 12066MA)Health Canada 76148 type III

Siemens Healthcare

Diagnostic Limited

2012/08/08Philips Medical Systems Multidiagnost Eleva-Flat Detector-Image Detector

(Model/Part no.: 0708MD02)Health Canada 76150 Type III


Kong Ltd

2012/08/08Smith & Nephew metal and PEEK suture anchors (include many from the

BIORAPTOR, FOOTPRINT, HEALICOIL and TWINFIX product lines.)

Smith & Nephew

Ltd.NA FSN Smith & Nephew Ltd.

2012/08/08

Prism Medical USA Stainless Steel 360760 Easy Swivel Carry Bar ( Model no:

360760 & Lot no.: Stainless Steel Version) Health Canada 73372 Type II N.A.

2012/08/08 Dectro International Apilux 2G Health Canada 75989 Type II N.A.

2012/08/085161401001)

Health Canada 76163 Type IIRoche Diagnostics

(Hong Kong) Ltd

2012/08/08M3535A, M3536A)

Health Canada 75332 Type IIPhilips Electronic Hong

Kong Ltd

2012/08/08

Medtronic Sofamor Danek USA Inc Vertex Select Spinal System Non-Sterile

(Model/Part no.: 7756035, 7756040, 7756045, EX0310714, EX0911070,

Health Canada 75531 Type IIMedtronic International

Ltd

2012/08/08

Synthes (Canada) Ltd Hemostatic Bone Putty

Model no: 08.901.001.97S, 08.901.001.98S, 08.901.001.99S, 08.901.001D,

VB1025.10S

Health Canada 76174 Type ISynthes (Hong Kong)

Ltd






















2012/08/08Linvatec Corporation D.B.A. ConMed Linvatec Pressft Suture Anchor with Hi-Fi


2012/08/08 no.: 80344-TD00214) Health Canada 75941 Type II N.A.

2012/08/08 80-001, 1521-80-002, 1521-80-003, 1521-80-004, 1521-80-005, 1521-80-006,

1521-80-007, 1521-80-008, 1521-80-009, 1521-80-010)

Health Canada 76001 Type IIJohnson & Johnson

(Hong Kong) Ltd.

2012/08/08ICU Medical A) Orbit 90 Subcutaneous Infusion Set, B) Orbit Micro

Subcutaneous Infusion SetHealth Canada 76320 Type II N.A.

2012/08/10Covidien DGPHP RFA High-Power single use grounding pads and Cool-tip

RFA Electrode Kits (containing DGPHP RFA High-Power single use grounding

Covidien Hong

Kong LtdN.A. NA

Covidien Hong Kong

Ltd

2012/08/14Siemens Healthcare Diagnostics ADVIA Centaur® HIV 1/O/2 Enhanced (EHIV)

reagent kit, Ref no: 01463908MHRA 2012/008/002/601/009 FSN

Siemens Healthcare

Diagnostic Limited

2012/08/14Siemens Healthcare Diagnostics ADVIA Centaur® BNP kit, ADVIA Centaur

TSH3 Ultra kit together with the ADVIA Centaur Multi-Diluent 1MHRA 2012/008/001/601/006 FSN

Siemens Healthcare

Diagnostic Limited

2012/08/14 Siemens Siemens syngo.plaza, all versions MHRA 2012/008/008/291/002 FSNSiemens Healthcare

Diagnostic Limited

2012/08/14GE Healthcare Innova 2121IQ, Innova 3131IQ Cardiovascular X-ray imaging

systemsMHRA 2012/008/008/081/016 FSN

GE Medical Systems

Hong Kong Ltd.

2012/08/14 Hospital Beds Health Canada NANotice to

HospitalsN.A.

2012/08/14BÂ RRX Medical HALOFLEX Energy Generators, Model no: 1190A-115A and

1190A-230AMHRA 2012/008/009/081/014 FSN Sky Medi-tech Ltd.

2012/08/14 Bio-Rad Medical Diagnostics Biotestcell-P3 MHRA 2012/008/007/291/005 FSN N.A.

2012/08/14 Biomet El-Tapered 100 +3mm Liner 32/39, Part no.: E1-103239 MHRA 2012/008/003/081/026 FSN N.A.

2012/08/14 BrainLab Cranial Navigation System – Standard Cranial Reference Array MHRA 2012/008/008/081/008 FSN BrainLAB Ltd

2012/08/14 Elekta Agility systems and Apex systems MHRA 2012/008/003/081/015 FSN Elekta Ltd

2012/08/14 MHRA 2012/008/003/081/006 FSNMedtronic International

Ltd

2012/08/14 Orthofix Inc ISKD - Intramedullary Skeletal Kinetic Distractor (Limb Lengthener) MHRA 2012/008/007/291/001 FSN N.A.

2012/08/14GE Healthcare Optima XR220amx, Optima XR200amx, Brivo XR285amx

Maintenance Service Procedure – Wheel ReplacementMHRA 2012/008/008/081/025 FSN

GE Medical Systems

Hong Kong Ltd.

2012/08/14

Invacare Robin EC-Track (ceiling hoist) – Lock Fixture of the Transit Coupling

System.

Item no.: 1491160-9010 and 1491160-0005 / number chapter 5.9 of the EC-

Track Installation Manual

MHRA 2012/005/022/401/018 FSN Direct Health Ltd.

2012/08/14NIHON KOHDEN NIHON KOHDEN defibrillators cardiolife TEC-8300K series

Model no.: TEC-8321K, TEC-8322K, TEC-8332K, TEC-8342K and TEC-8352KMHRA 2012/008/006/081/019 FSN N.A.

2012/08/16affected lot no.: 093309)

FDA Z-2155-2012 Class II Stryker China Ltd

2012/08/16Roche Molecular Systems, Inc. cobas KRAS Mutation Test (Model/Part no.:

05852170190; lot no.: PO6778)FDA Z-2159-2012 Class III

Roche Diagnostics

(Hong Kong) Ltd

2012/08/16

Baxter Healthcare Corp AUTOMIX High Speed Compounder System,

AUTOMIX Plus High Speed Compounder System, AUTOMIX 3+3 Compounder

System 115V/ 230V, AUTOMIX 3+3 Compounder with Accusource Monitoring FDA

Z-2139-2012, Z-2140-2012, Z-

2141-2012, Z-2142-2012Class I Baxter Healthcare Ltd

2012/08/16GE OEC Medical Systems The FluroTrak Spinal Navigation Application on the

OEC 9900 EliteNavFDA Z-2136-2012 Class I

GE Medical Systems

Hong Kong Ltd.

2012/08/17

Shanghai Shenfeng, China L-Gel Ultrasound Transmission Gel, manufactured

between June 2011 and May 2012

Affected lot no.: 2011 06 17 to 2012 04 09

TGA NA Alerts N.A.









http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/medeff/advisories-avis/prof/2012/hospital_bed-lit_hopital_2_nth-aah-eng.pdf











http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2155-2012&w=08152012&




http://www.tga.gov.au/safety/alerts-device-l-gel-120816.htm

2012/08/17Terumo CVS Terumo Advanced Perfusion System 1: Interface Modules for CDI

Systems & Serial Data TransferTerumo AA-2012-012-R NA

TERUMO CHINA (H.K.)

LTD.

2012/08/20 Baxter Healthcare Ltd Sterile Water for Irrigation 1000ml MHRA MDA/2012/057 MDA Baxter Healthcare Ltd

2012/08/20 Varian Medical Systems Clinac, Trilogy, Novalis Tx and Unique jaw carriers

Varian Medical

Systems Pacific

Inc.

CP-08881 NAVarian Medical Systems

Pacific Inc.

2012/08/21Stryker Spine Torque Wrench: XIA3 – MANTIS REDUX – SPECIALTY

AUDIBLEMHRA 2012/008/010/081/013 FSN Stryker China Ltd

2012/08/21 Siemens Artiste MV Syngo RT Therapist Health Canada 76625 Type IISiemens Healthcare

Diagnostic Limited

2012/08/21 Getinge Castle Modell 233 Steam Sterilizer Health Canada 76462 Type II N.A.

2012/08/21Fehling Instruments GmbH & Co. KG Sterilization containers UBD-0 and UBH-

0 with quick-lock filterMHRA 2012/008/013/291/004 FSN N.A.

2012/08/21Galil Medical FPRCH6000 – Visual-ICE® Cryoablation System [Serial no.:

VL0014, VL0015, and VL0016]MHRA 2012/008/010/601/006 FSN N.A.

2012/08/21 Invacare Zimma Walking Frames [Model no: 1536700] MHRA 2012/005/009/081/016 FSN Direct Health Ltd.

2012/08/21Grenier Bio One North America Inc. 3 mL 9NC Coagulation Tube 3.2% [Model

no.: 454334 & Lot no.: B041206]Health Canada 759748 Type I Mekim Ltd

2012/08/21Oxoid Company Chromogenic ESBL Isolation Agar [Part no.: MP0430; Lot no.:

2149]Health Canada 73288 Type II

Thermo Fisher

Scientific (Hong Kong)

2012/08/21Baxter Healthcare Corp Basic Solution Set, 1.2 Micron Filter [Model no.:

JC5467; Serial no.: R11K03207, R11K03199, R11K03181, R12A20028]Health Canada 76278 Type II Baxter Healthcare Ltd

2012/08/21Hospira Inc. 100 mL Burette Set, Convertible Pin, 77 inch [Model no:

12722001; Lot no.: 960985H]Health Canada 76431 Type II Hospira Limited

2012/08/21Andocor 24 fr Arterial Perfusion Cannulae, Product Code.: A24061V, Batch no.:

12-02-4222MHRA 2012/006/008/291/012 FSN N.A.

2012/08/21 Bioconnect Systems Optiflow Anastomotic Connector MHRA 2012/008/014/601/007 FSN N.A.

2012/08/21 Central Medical Supplies Kanmed Water Mattress, Part no.: TEK-BW-50-003 MHRA 2012/001/019/401/004 FSNAssociated Medical

Supplies Company, Ltd.

2012/08/21 Welch Allyn Inc A) KleenSpec Single Use Vaginal Speculum; B) Speculum Health Canada 76145 Type IIIUltronics Enterprises

Ltd

2012/08/21Dominion Biologicals Ltd ELU Kit Plus Red Cell Elution System, Model no:

580073, Lot no.: ELU042Health Canada 76609 Type III Uninet Technology LTD

2012/08/21Siemens Dimension Vista System-Theophylline Assay, Model no: K4071, Lot

no.: 12135AE, 12171BBHealth Canada 76624 Type III

Siemens Healthcare

Diagnostic Limited

2012/08/21 Respironics Inc. (Philips). Respironics V60 VentilatorMHRA and

Health Canada

2012/008/015/081/026 and

76748FSN and Type II Celki Medical Company

2012/08/21Siemens Healthcare Diagnostics ADVIA Centaur FSH assay on the ADVIA

Centaur and ADVIA Centaur XP system, Calibrator B lot 40 and below.MHRA 2012/008/008/601/006 FSN

Siemens Healthcare

Diagnostic Limited

2012/08/21Siemens Healthcare Diagnostics ADVIA Centaur Prolactin assay on the ADVIA

Centaur CP system, Calibrator B lot 40 and belowMHRA 2012/008/008/601/007 FSN

Siemens Healthcare

Diagnostic Limited

2012/08/21 Model no.: 60+00007791, 60+00007792

Affected lot number: Model L9M21000

Health Canada 76401 Type IIAGFA Hong Kong

Limited

2012/08/2110 and affected Lot no.: ZS131763, W37630, W38887, X05215, X05752,

X11934, X18594)Health Canada 76151 Type II Stryker China Ltd

2012/08/21 Terumo CVS Roller Pump Encoder Cable Health Canada 74574 Type IITERUMO CHINA (H.K.)

LTD.

2012/08/21no.: 3550180)


2012/08/21Model no.: PLU817


http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON179798

















http://www.mhra.gov.uk/home/groups/fsn/documents/fieldsafetynotice/con179764.pdfhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_july-sept_2012-eng.php

http://www.mhra.gov.uk/home/groups/fsn/documents/fieldsafetynotice/con179764.pdfhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_july-sept_2012-eng.php








2012/08/21

Beckman Coulter Inc. A) RF Latex Assay (ON AU5400)

B) RF Latex Assay (ON AU2700)

C) RF Latex Assay For AU Chemistry Systems

Model no.: OSR61105

Health Canada 75392 Type IIBeckman Coulter Hong

Kong Ltd

2012/08/23 CareFusion Alaris Pump Module, Model 8100 FDA NAMedWatch, MD

recall


Ltd.

2012/08/23 Invacare Powered Wheelchair (all chairs in the Harrier range) MHRA MDA/2012/060 MDA Direct Health Ltd.

2012/08/24 GE Healthcare GE Advantage Workstations FDA Z-2203-2012 Class IIGE Medical Systems

Hong Kong Ltd.

2012/08/24CareFusion Alaris Pump Module Model 8100 (manufactured between August

2010 and July 2011)FDA Z-2185-2012 Class I


Ltd.

2012/08/24Covidien DUET™ TRS Universal Straight and Articulating Single Use Loading

Units

Covidien Hong

Kong LtdN.A. NA

Covidien Hong Kong

Ltd

2012/08/24

Philips Medical Systems Essenta DR

Model no.: 712070

Affected Serial no.: SN09000006/ SN09000007/ SN10000033/ SN10000014/

SN100000654/ SN08000092/ SN08000050

FDA Z-2207-2012 Class IIPhilips Electronic Hong

Kong Ltd

2012/08/24 Teleflex Medical TAUT (Catalog no.: PI-128) FDA Z-2186-2012 Class III N.A.

2012/08/29 Angiotech IQ Geometry Slit knives MHRA 2012/008/017/081/019 FSN N.A.

2012/08/29DiaSys Diagnostic Systems Creatinine PAP FS, Cat. No.: 1 1759 / Creatinine

FS Cat. No. 1 1711MHRA 2012/008/021/291/007 FSN N.A.

2012/08/29Elekta Digital Accelerators from 105345 to 151675 (inclusive), fitted with X-ray

Volume Imaging System (XVI)MHRA 2012/008/022/081/011 FSN Elekta Ltd

2012/08/29Philips Healthcare Brilliance 6, 10, 16, 40, 64, and Brilliance CT Big Bore

(Problems with Damage of Foot Switch Cover)MHRA 2012/008/021/291/003 FSN


Kong Ltd

2012/08/29Roche Diagnostics Symantec pcAnywhere software used in Total System

Manager (TSM) MHRA 2012/008/022/081/012 FSN

Roche Diagnostics

(Hong Kong) Ltd

2012/08/29 Sequana Medical AG ALFApump system MHRA 2012/008/022/081/020 FSN N.A.

2012/08/29 Elekta SL75/5 MHRA 2012/008/014/081/009 FSN Elekta Ltd

2012/08/29Gen-Probe GTI Diagnostics LIFECODES PAK12G Assay Kit (Problems with

Positive Control)MHRA 2012/008/020/081/007 FSN bioMerieux China Ltd.

2012/08/29Integra LifeSciences Corporation MAYFIELD® Left Gel Pad, MAYFIELD® Right

Gel Pad [Model/ no.: 440C1011 & 440C1012. ; Lot no.: 093990 and 093984]MHRA 2012/008/017/291/002 FSN Milverton Limited

2012/08/29Hill-Rom VersaCare® Bed (Siderail Caregiver PC Board Chip Issue) [Model

no.: Revision E through J;Serial no.: H345AD5880 to N138AL9061]

Solar-Med

LimitedMod 496 NA Solar-Med Limited

2012/08/29Pentron Clinical TempSpan CMT [Model no.: N69CA & Lot no.: 3534044,

3596030, 3624653, 3624656]

Sybron Dental

SpecialtiesNA NA

Citicon (Hong Kong)

Limited

2012/08/30GE OEC Medical Systems 892.1650 Image-intensified fluoroscopic x-ray

system [Model no.: HDS721616PLAT80 ; GE Healthcare part number 5304649]FDA Z-2240-2012 Class II

GE Medical Systems

Hong Kong Ltd.

2012/08/30

Beckman Coulter Inc. A) UniCel DxI 800 Access Immunoassay Systems; B)

UniCel DxI 600 Access Immunoassay Systems; C) UniCel DxC 660i, 680i,

860i, 880i SYNCHRON Access Clinical Systems; [Software anomaly]

FDA Z-2257-2012 to Z-2259-2012 Class IIBeckman Coulter Hong

Kong Ltd

2012/08/30Biomet UK Oxford Gap Gauge SML 3/4mm, Cat no.: 32-422801, Lot no.:

ZB111101, ZBll1201, ZB120101, ZB120501, ZB111102, and ZB120201FDA Z2224-2012 Class II N.A.

2012/08/31Varian Medical Systems Eclipse Treatment Planning System [Versions 8.9 and

10.0] Ref.:CP-08922

Varian Medical

SystemsCP-08922 FSCA

Varian Medical Systems

Pacific Inc.

2012/08/31 Fake dental equipment online MHRA N.A. Press Release N.A.


http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm316612.htm


















http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON181209

Date of Issue

(YYYY/MM/D

D)

Description of ProductSource of


Alert Type by

SourceLocal Agent

2012/07/03Liko (a Hill-Rom company) Likorall® 200 Ceiling Lift (production dates: Oct to

Nov 2011) (Model/Part no.: 312101; Serial no: 8405801 to 8405856)MHRA 2012/006/029/081/011 FSN N.A.

2012/07/03 Terumo CVS Terumo Advanced Perfusion System 1 -Centrifugal system TERUMO

CHINA (H.K.) AA-2012-001-C

TERUMO

CHINA (H.K.)

TERUMO CHINA (H.K.)

LTD.

2012/07/03Terumo CVS Terumo Advanced Perfusion System 1 - Electronic Patient Gas

System

TERUMO

CHINA (H.K.) AA-2012-002-C

TERUMO

CHINA (H.K.)

TERUMO CHINA (H.K.)

LTD.

2012/07/03 Terumo CVS Terumo Advanced Perfusion System 1 - Battery CapacityTERUMO

CHINA (H.K.) AA-2012-004-C

TERUMO

CHINA (H.K.)

TERUMO CHINA (H.K.)

LTD.

2012/07/03 Terumo CVS Terumo Advanced Perfusion System 1 - Roller PumpTERUMO

CHINA (H.K.) AA-2012-010-C

TERUMO

CHINA (H.K.)

TERUMO CHINA (H.K.)

LTD.

2012/07/03 Terumo CVS Terumo Advanced Perfusion System 1 - Central Control monitorTERUMO

CHINA (H.K.) AA-2011-020-C

TERUMO

CHINA (H.K.)

TERUMO CHINA (H.K.)

LTD.

2012/07/03Stryker Endoscopy Formula Shaver Hand Control and Formula 180 (Catalogue

no.: 0375704500E and 0375708500E)MHRA 2012/006/011/081/014 FSN Stryker China Ltd

2012/07/03 ev3 ev3 Onyx Liquid Embolic System FDA N.A. N.A. Sinomed Company Ltd.

2012/07/03

B. Braun Avitum (UK) Ltd Hemodialyser xevonta Hi 20 [Model no.: 7204665;

Batch no: 140350412] MHRA 2012/006/020/081/011 FSN United Base (HK) Ltd

2012/07/03

Integra Lifesciences (Ascension Orthopedics) PyroTITAN Humeral Resurfacing

Arthroplasty (CHRA) [Ref no.: CHRA-910-47/20-WW; Batch no.: 09-2119] MHRA 2012/006/027/081/004 FSN N.A.

2012/07/03Agfa Healthcare IMPAX 6.4 Server Software integrated with Agfa RIS, and use

Enterprise QueryMHRA 2012/006/027/081/002 FSN

AGFA Hong Kong

Limited

2012/07/04Advanced Sterilization Products STERRAD® CYCLESURE® 24 Biological

IndicatorsFDA N.A.

Safety

Communication

Johnson & Johnson

Medical (HK)

2012/07/05BD BD PrepStain™ Diti 1.2 (Cat no.: Diti 1.2 (750-07024-00, SAP 490670) and

Diti 1.2 upgrde kits (Cat no. 750-07377-02, SAP 491074)BD N.A. BD BD

2012/07/06

Philips Healthcare Philips HeartStart MRx monitor/defibrillators Models:

M3535A, M3536A, M3536M4, M3536M5, and M3536M6 FDA Z-1896-2012 Class IIPhilips Electronic Hong

Kong Ltd

2012/07/06 GE OEC Medical Systems OEC Uroview 2800 (Model no.: A349855) FDA Z-1865-2012 Class IIGE Medical Systems

Hong Kong Ltd.

2012/07/09 Maquet FLOW-i Anesthesia System C20, C30 and C40 FDA N.A. Class IMAQUET Hong Kong

Limited

2012/07/09

Standard Diagnostics, Inc (A) SD BIOLINE HIV Ag/Ab Combo PQDx 0069-012-

00; (B) SD BIOLINE HIV-1/2 3.0 PQDx 0027-012-00; (C) SD BIOLINE Malaria

Ag P.f/Pan PQDx 003 0-012-00; (D) SD BIOLINE Malaria Ag P.f PQDx 0031-

WHO N.A.Complaints and

Product AlertsBio-Asia

2012/07/10 Farla Medical Ltd Minor Surgery Pack Standard MHRA 2012/007/002/291/004 FSN N.A.

2012/07/10 Exactech Inc Equinoxe Shoulder System MHRA 2012/007/002/081/005 FSN N.A.

2012/07/10

Thermo Fisher Scientific Oxid Antimicrobial Susceptiability Testing Disc FOX30

MHRA 2012/007/003/601/006 FSNThermo Fisher

Scientific (HK)

2012/07/10 Unomedical Limited UK Neria Steel Cannula infusion sets MHRA 2011/005/012/401/014 FSN N.A.

Major Safety Alerts in July 2012





http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm310199.htm




http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm310549.htm

http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Event-Detail.cfm?action=detail&id=62333&w=07052012


http://www.fda.gov/Safety/Recalls/ucm310815.htm

http://www.who.int/diagnostics_laboratory/procurement/120626_sdbioline_noc.pdf





2012/07/10

Vygon (UK) Ltd Vygon Bionector S and Aurum glass syringes

852201F, 896.21 & 896.23

MHRA 2012/007/004/601/008 FSN N.A.

2012/07/10

Roche Diagnostics Symantec pcAnywhere software used in Data Station

AMPLILINK, LightCycler 1.2 (CE-IVD, US-IVD)*, LightCycler 2.0 (CE-IVD, US-

IVD)*, cobas® 8000 data manager (All Versions), COBAS INTEGRA® 400,

COBAS INTEGRA® 400 plus

MHRA2012/006/027/081/010

FSNRoche Diagnostics

(Hong Kong) Ltd

2012/07/10 Silentia AB All products in Silentia Screen System MHRA 2012/007/003/291/012 FSN Viking Group (HK) Ltd

2012/07/10Siemens IMMULlTE/IMMULITE 1000 Third-Generation TSH (Part no.:

LKTS1/5; Lot no.: 428, 431, 432)MHRA 2012/006/028/601/001 FSN

Siemens Healthcare

Diagnostic Limited

2012/07/10 Ottobock XENO stand-up chair MHRA 2012/006/022/291/021 FSN N.A.

2012/07/10Kimberly-Clark ULTRA Fabric Reinforced Surgical Gown X-Large, Sterile

(Product Code.: 95221)Kimberly-Clark N.A. Kimberly-Clark

Shun On Healthcare

Limited

2012/07/10Elekta Inc. IMPAC Medical Systems, Inc Monaco RFC 35238 and Focal RFC

35256 (Affected versions.: Monaco Release 3.10 and Focal Release 4.64.00)MHRA 2012/007/004/081/018 FSN Elekta Ltd

2012/07/11

Maquet Cardiopulmonary AG A) Perfusion Pack Bioline, B) Standard Pump

Pack Bioline, C) Heart Lung Pack Bioline, D) ECLS Pack, Bioline Coated Kit, E)

Custom Pack with Softline, F) Quadrox-I Adult Oxygenator with Integrated

Hardshell Reservoir, G) Quadrox-I Adult Oxygenator, H) Permanent Life

Support Set, I ) Small Adult Heart Lung Perfusion Pack with Softline, J)

Quadrox-I Adult Oxygenator with Integrated Hardshell Reservoir (Softline), K)

Quadrox-I Small Adult Oxygenator with Integrated Hardshell Reservoir (with

Bioline), L) Quadrox Oxygenator with INtegrated Hardsteel Reservoir, M)

Quadrox-I Pediatric Oxygenator with Integrated Hardshell Reservoir, N)

Quadrox-I Neonatal Oxygenator with Integrated Hardshell Reservoir, O)

Quadrox-ID Adult Oxygenator (with Bioline), P) Quadrox-ID Adult Oxygenator

Health Canada 74853 Type IIMAQUET Hong Kong

Limited

2012/07/11 DIAGNOSTICA STAGO STA Satellite (Model/Part no.: 58104) Health Canada 75215 Type II Healthpro

2012/07/11Maquet Cardiovascular Paediatric Arterial Cannula (Model no.: 161412, lot no.:

92051578, 92048923)Health Canada 74337 Type II

Shun On Healthcare

Limited/MAQUET Hong

Kong Limited

2012/07/11Stryker Endoscopy IFU for Arthoscope and Hardware Set Tray (Part no.: 0233-

032-116)Health Canada 75386 Type II Stryker China Ltd

2012/07/11 Varian Eclipse Treatment Planning System V8.8 (Model no.: 100042024) Health Canada 75441 Type IIVarian Medical Systems

Pacific Inc.

2012/07/11

Varian A) Eclipse Ocular Proton Planning V. 1.1

B) RapidArc, also know as Dose Dynamic Arc / Volumetric Modulated Arc

Therapy

Health Canada 74232 Type IIVarian Medical Systems

Pacific Inc.

2012/07/11

GE Medical Systems A) 3.0T Signa HDX MR System - Main Unit (P/N:

M3335JK)

B) 1.5 T Signa HDX MR System - Main Unit (P/N: M3335J, M3335JA,

M3335JB, M3335JG)

C) Discovery MR750 MR System - Main Unit (P/N: M7000MC)

D) Signa HDXT 1.5T MR System - Main Unit (P/N: SIGNA HDXT 1.5T MR

SYSTEM)

E) Discovery MR450 1.5T MR Sytem - Main Unit (P/N: SIGNA HDXT 1.5T MR

SYSTEM)

F) Optima MR450W MRI System - 16CH - Main Unit (P/N: M7000WD)


Hong Kong Ltd.

2012/07/11Life Technologies Corporation (Invitrogen) DPB1 SSP UniTray Kit / DPB1 SSP

UniTray Kit with Taq Polymerase (P/N: 451606D, 451616D)Health Canada 75027 Type II

Invitrogen Hong Kong

Limited

2012/07/11 Radiometer Medical APS SafePico Aspirator Kits Health Canada 72340 Type IIIRadiometer China

(RCHN)
















2012/07/11 Roche Diagnostics Online DAT Amphetamines II for Cobas Integra Health Canada 75330 Type IIIRoche Diagnostics

(Hong Kong) Ltd

2012/07/11 Kerr Corporation Tempspan Clear Matrix Health Canada 75387 Type IIICiticon (Hong Kong)

Limited

2012/07/11 GE Medical Systems AW Server Health Canada 75050 Type IIIGE Medical Systems

Hong Kong Ltd.

2012/07/11TRUMPF Medical Systems iLED 5 Ligting System, Ondal AC3000, FA AC3

Spring Arm( Model no.: 1851710, 1851710)Health Canada 75334 Type III

InnoTech Medical

Trading, Marty Tang

2012/07/11 DAKO Denmark A/S Intrastain Kit Health Canada 75256 Type III Gene Company Ltd.

2012/07/11 Hill-Rom Advanta 2 (P1190) Health Canada 74341 Type II Solar-Med Limited

2012/07/11Bio-RAD Laboratories Liquichek Blood Gas Plus E Ctl. Niveaux 1,2,3 and

Trilevel MiniPak (Model/Part no.: 576, 577, 578, 575X)Health Canada 75266 Type II Bio-Rad Pacific Ltd.

2012/07/11Kerr Corporation, also trading as Pentron Clinical TempSpan CMT (Model/Part

no.: N69CA)Health Canada 75337 Type II N.A.

2012/07/11Sybron Dental Specialties, Inc Correct Plus Bite Superfast (Part numbers.:

Q34IA, Q34IC)Firm NA

Sybron Dental

SpecialitiesCiticon (HK) Ltd

2012/07/11 Philips Gemini, Precedence, and Brilliance Firm CIL 10-012-347102 Rev 2

Philips

Electronics

Hong Kong Ltd

Philips Electronics

Hong Kong Ltd

2012/07/11 Battlecreek Equipment Co. Thermophore Automatic Moist Heat Pack Health Canada 74555 Type II N.A.

2012/07/11Life Technologies Corporation (Invitrogen) A) Allset Gold SSP HLA-B Locus

High Res. Kit, B) B17 SSP UniTray Kit / B Locus High Res SSP UniTray KitHealth Canada 74840 Type II

Invitrogen Hong Kong

Limited

2012/07/11 Ellman International Inc D110FSHP and D115FSHP Reusable Handpieces Health Canada 75149 Type II N.A.

2012/07/12

Alere San Diego Alere Triage Diagnostic Tests (Multiple Tests), including

Triage CardioProfiler Panel, Triage Cardiac Panel, Triage Profiler SOB Panel,

Triage BNP, and Triage D-dimer

FDA N.A. Class I N.A.

2012/07/12Pride Mobility Products Corp Victory 9 with Power Seat (SC609PS) Motorized

wheelchair with elevating seat.FDA Z-1941-2012 Class II N.A.

2012/07/12 Philips Healthcare Philips Xcelera Connect, Software R2.1 L 1 SP2 FDA Z-1942-2012 Class IIPhilips Electronic Hong

Kong Ltd

2012/07/13 Nobel Biocare AB NobelClinician Nobel Biocare AE1119 N.A. N.A.

2012/07/13 Nobel Biocare AB Abutment MZ Straumann BL NC Nobel Biocare AE1220 N.A. N.A.

2012/07/16 Westone Laboratories, Inc. Oto-Ease® ear lubricant FDA N.A.Firm Press

ReleaseN.A.

2012/07/16

Haemotronic and Bellco A) Aquarius haemofiltration machine consumables; B)

BM25 haemofiltration machine consumables (All consumables are supplied by

Baxter Healthcare Ltd)

MHRA MDA/2012/045 MDA Baxter Healthcare Ltd

2012/07/17 PENTAX PENTAX EG-3870UTK Ultrasound Video Gastroscope MHRA 2012/007/009/081/015 FSN N.A.

2012/07/17 Perkin Elmer Genetic Screening Processor (GSP) MHRA 2012/005/028/401/016 FSN N.A.

2012/07/17SuperDimension SuperDimension® Systems, AAS00016-xxx, Software

Version: 4.0-4.9MHRA 2012/007/004/081/001 FSN N.A.

2012/07/17

GE Healthcare Discovery MR450, Optima MR450w (with and without GEM),

Discovery MR750, Optima MR360, Brivo MR355, Signa HDx, Signa HDxt,

Signa Vibrant, Signa HDi, Signa HDe 1.5T, Ovation HD, and Profile HD


Hong Kong Ltd.

2012/07/17 Zhengzhou Tianjie Electronic Equipment Co Tianjie Dental Falcon MHRA MDA/2012/046 MDAZhengzhou Tianjie

Electronic Equipment

2012/07/17Smith & Nephew DYONICS BONECUTTER ELECTROBLADE (4.5 and 5.5

mm)

Smith & Nephew

Ltd.NA class II Smith & Nephew Ltd.

2012/07/17

Philips Healthcare HeartStart MRx monitor/defibrillators (All Philips HeartStart

MRx monitor/defibrillators manufactured prior to June 2012 and used in

external transport and Emergency Medical Service (EMS) environments.)

Philips

Electronics HK

Ltd.

NA FSNPhilips Electronic Hong

Kong Ltd






















2012/07/17Siemens Healthcare Diagnostics Inc. Dimension® RxL - Reagent Management

System (RMS) Power Cord PlugMHRA 2012/007/009/601/003 FSN

Siemens Healthcare

Diagnostic Limited

2012/07/17 Smith & Nephew Endoscopy Twinfix Ultra Ti Suture Anchor, 5.5 mm MHRA 2012/007/009/081/004 FSN Smith & Nephew Ltd.

2012/07/17 Stryker Osteosynthesis Telescopic Struts Hoffmann LRF MHRA 2012/007/006/291/002 FSN Stryker China Ltd

2012/07/18 Covidien Shiley Reusable Cannula Cuffed Tracheostomy TubesCovidien Hong

Kong LtdN.A. FSN

Covidien Hong Kong

Ltd

2012/07/19Carefusion EnVe Ventilator, manufactured between December 2010 and

January 2012FDA Z-2006-2012 Class I


Ltd.

2012/07/19

Alere San Diego Alere Triage CardioProfiler Panel PN 97100CP, Alere Triage

Cardiac Panel PN 97000HS, Alere Triage Profiler SOB Panel PN 97300, Alere

Triage BNP PN 98000XR, Triage D-dimer PN 98100

FDA Z-1928-2012 to Z-1932-2012 Class I N.A.

2012/07/19GE OEC Medical Systems InstaTrak with Multiple Dataset Navigation,

892.2050 SystemFDA Z-1985-2012 Class I

GE Medical Systems

Hong Kong Ltd.

2012/07/19Philips Healthcare HeartStart MRx monitor/defibrillatorss. M3536A with

software versions, R.03.03FDA Z-1986-2012 Class II


Kong Ltd

2012/07/19GE Healthcare GE Advantage CT/PET Fusion for Advantage Windows

Workstation with Volume View CT Colonography/Navigator 2 software, FDA Z-1960-2012 Class II

GE Medical Systems

Hong Kong Ltd.

2012/07/19

Civco Medical Instruments Inc CIVCO VirtuTRAX Instrument Navigator: (Ref.

5350925);(Ref. 610-1080)

CIVCO General Purpose Sensor: (Ref. 10441627); (Ref. 610-1066); (Ref. 610-

1067)

FDA Z-1952-2012 to Z-1956-2012 Class II The Vita Company Ltd.

2012/07/20Sybron Dental Specialties, Inc Discovery Trays (Part no.: 16188 – child size,

16189 – small size)

Sybron Dental

SpecialitiesNA FSN Citicon (HK) Ltd

2012/07/20Ormco Corporation AEZ Mini Distal Cutter w/ Hold Long (Part no.: 803-0501;

Lot no.: 11M36M)

Sybron Dental

SpecialitiesNA FSCA

Young's L&S Dental

Supplies Ltd--Hong

2012/07/23 Stryker Australia Pty ABG II Modular Femoral Stem and Modular Neck TGA NA FSN Stryker China Ltd

2012/07/23

PAUL HARTMANN Disposable surgical gown-- Foliodress [Comfort Basic,

Comfort Perfect, Comfort Special, Protect Standard, Protect Reinforced,

Protect A Standard Protect A Reinforced]

PAUL

HARTMANN

Asia-Pacific Ltd

NA FSCAPAUL HARTMANN Asia-

Pacific Ltd

2012/07/24Getinge Lancer SA Channel separator LFC-S-05 used with Fibrocleaners,

Poka Yoke, Ed FLOWMHRA 2012/007/009/081/021 FSN N.A.

2012/07/24Kreatech Diagnostics FIP1L1-CHIC2-PDGFRA triple color deletion/fusion

probe (KBI-10007)MHRA 2012/006/008/401/013 FSN N.A.

2012/07/24Microtek Medical (Intuitive Surgical) da Vinci Surgical Systems [da vinci, da

vinci S, da vinci Si, da vinci Si-e]MHRA 2012/007/013/081/013 FSN Chindex

2012/07/24Philips Medical Systems Brilliance series 6, 16, 40, 64, CT Big Bore, iCT, and

iCT SP (Problems with J-Bracket Bolts)MHRA 2012/007/017/291/004 FSN


Kong Ltd

2012/07/24 R82 A/S Mustang walking aids MHRA 2012/007/017/081/018 FSN N.A.

2012/07/24Wright Medical Technology Inc. Profemur TL, Profemur tapered, Profemur Z

and Profemur Z plasma Packaged before February 2008MHRA 2012/007/019/081/003 FSN

Hong Kin Medical

Instrument Limited

2012/07/24 EMS Medical Neonatal and paediatric endotracheal tube clamp/holder MHRA MDA/2012/049 MDA N.A.

2012/07/24 Animas Corporation Animas Insulin Pump MHRA 2012/007/013/081/020 FSNJohnson & Johnson

Medical (HK)

2012/07/24 ArjoHuntleigh Pegasus® UltraLo low height electric bed frame MHRA 2010/012/021/401/004 FSNArjo Huntleigh (Hong

Kong) Ltd.

2012/07/24ConforMIS iTotal CR Tibial Poly Inserts (M57250600010 – iTotal CR, Left

Knee, and M57250600020 – iTotal CR, Right Knee)MHRA 2012/007/012/081/002 FSN N.A.

2012/07/24 Biomet Orthopedics Optipac 60 Refobacin bone cement R MHRA 2012/007/019/081/016 FSN N.A.

2012/07/25 bioMerieux Vidas System - EBV VCA/EA IgC Health Canada 75755 Type II bioMerieux China Ltd.

2012/07/25 Philips Medical Systems Essenta Dr. Compact (Model no.: 9890 010 88201) Health Canada 75781 Type IIPhilips Electronic Hong

Kong Ltd























2012/07/25Varian Medical Systems CT/MR Ring and Tandem Applicator Set (Model no.:

AL13017000)Health Canada 75810 Type II


Pacific Inc.

2012/07/25

Immucor Inc. Gamma-Clone Anti-LE B Blood Grouping Reagent

Health Canada 65091 Type II Uninet Technology LTD

2012/07/25Ortho-Clinical Diagnostics Inc. VITROS Chemistry Products DGXN Slides (Part

no.: 8343386)Health Canada 75644 Type II

Ortho Clinical

Diagnostics

2012/07/25 Varian Medical Systems Inc. Eclipse Version 6.5 Health Canada 75759 Type IIVarian Medical Systems

Pacific Inc.

2012/07/25

Howmedica Osteonics Corporation A) Rejuvenate Modular Neck, 0 DEG

B) Rejuvenate Modular Neck, 8 DEG

C) Rejuvenate Modular Neck, 16 DEG

D) Rejuvenate SPT Modular Stem, Straight Press-Fit Texture TMFZ


2012/07/2548770614, 48770616)

Health Canada 75695 Type II Stryker China Ltd

2012/07/25

Beckman Coulter Inc A) Avanti J26XP Centrifuge; B) Avanti J26XPI Centrifuge;

C) Avanti J-HC Centrifuge; D) Optima L Centrifuge; E) Optima LXP Centrifuge;

F) Optima Max-XP Centrifuge; G) Avanti J30-I Centrifuge


Kong Ltd

2012/07/25 Beckman Coulter Inc Coulter S-Cal Calibrator Kits Health Canada 75391 Type IIIBeckman Coulter Hong

Kong Ltd

2012/07/25 Beckman Coulter Inc Coulter AcT 5diff Control Plus Health Canada 65922 Type IIIBeckman Coulter Hong

Kong Ltd

2012/07/25 Immucor Inc PBS and Waste Container on Gallileo Echo, Model no.: 0087000 Health Canada 75516 Type III Uninet Technology LTD

2012/07/25Sierra Scientific Instruments LLC, a Given Imaging Company A) MSS-2155

Manoshield EG; B) MSS-3599 Manoshield AR; C) MSS-4360 Manoshield SDHealth Canada 67568 Type II

Given Imaging (Asia)

Company Ltd.

2012/07/25bioMerieux Inc. BACT/ALERT 3D B.40.XX Firmware [Model No.: 411814,

411815, 411818, 411925]Health Canada 75277 Type II bioMerieux China Ltd.

2012/07/25SCC Soft Computer SoftBank II v.23.0, 23.1, 23.2, 25.0, 25.1 [Used with

Softscape GUI V. 1.2.0.7 to 1.2.0.15 & V. 1.3.0.4 to 1.3.0.5]Health Canada 64364 Type II N.A.

2012/07/25Fisher and Paykel Healthcare Ltd. A) Auto Icon ICONAAN [Lot no.: 101101 to

110517]; B) Premo Icon ICONPBN [Lot no.: 100630 to 110511]Health Canada 67641 Type II

Fisher & Paykel

Healthcare Limited

2012/07/25

Varian Medical Systems Inc. A) Aria Practice Management - 4D Integrated

Treatment Console [V8.1.2, V8.6, V8.8]; B) Truebeam (Radiotherapy

Configuration) - Main Unit [H191044, H191069, H191071, H191038, H191074]


Pacific Inc.

2012/07/25Siemens Healthcare Diagnostics Inc. Vista Vancomycin Vanc Flex Reagent

(Model/Part no.: K4086; Affected lot no.: 12095AD)Health Canada 75029 type III

Siemens Healthcare

Diagnostic Limited

2012/07/25Helix Medical LLC. Also trading as Inhealth Technologies Adjustable

Tracheostoma Kits (Model/Part no.: BE8024H, Affected lot no.: 967741, Health Canada 64815 type III N.A.

2012/07/25 Kerr Corporation TempBond NE Health Canada 75913 Type IIICiticon (Hong Kong)

Limited

2012/07/25Atricure Inc. Atricure Cryo Module (Model/Part no.: ACM1; Affected lot no.:

37559-01)Health Canada 75938 type III N.A.

2012/07/26 LMA North America Inc LMA Esophageal Intubation Detector (EID100) FDA Z-2022-2012 Class II N.A.

2012/07/26

GE OEC Medical Systems A)OEC 9900 Elite, OEC 9900 Elite MD Motorized C-

arm System

B) OEC 9800, OEC FluoroTrak 9800 Plus, OEC 9800 Plus, OEC 9800 MD

Motorized C-arm System

C) OEC 8800 Flexiview

FDA Z-2025-2012 to Z-2027-2012 Class IIGE Medical Systems

Hong Kong Ltd.

2012/07/26Gulf Medical Fiberoptics, Inc. GMF-RC65 Replacement Surgical Headlight

Cable for Cogent Micro-linkFDA Z-2029-2012 Class II N.A.






















2012/07/26 Varian Medical Systems Inc. Eclipse Treatment Planning System H48 FDA Z-2041-2012 Class IIVarian Medical Systems

Pacific Inc.

2012/07/26

EKOS Corporation EkoSonic MACH4 Endovascular Device (Catalog #500-

55106, 500-55112; 500-55118; 500-55124; 500-55130; 500-55140; 500-55150;

500-54106; 500-56130; 500-56140; 500-56150)


2012/07/26

Stingray Surgical Products, LLC Bipolar Forceps model number: S02-XXX, S03-

XXX, P02-XXX, and P03-XXX. "Instructions For Use" (QF7.5.1A.R01 thru

QF7.5.1A.R06 Care and Handling of Bipolar Forceps.


2012/07/26

Terumo CVS Terumo Advanced Perfusion System 1, System 1 Base 100/120V

and System 1 Base, 220/240V (Red X error message indicating a loss or

fluctuation of internal power on one side of the system's base)

FDA Z-2020-2012, Z-2021-2012 Class IITERUMO CHINA (H.K.)

LTD.

2012/07/26Terumo CVS Terumo Advanced Perfusion System 1, System 1 Base 100/120V

and System 1 Base, 220/240V (communications or power failures)FDA Z-2009-2012, Z-2010-2012 Class II

TERUMO CHINA (H.K.)

LTD.

2012/07/26 Spacelabs Medical, Inc. XPREZZON Bedside Monitor_91393 FDA Z-2019-2012 class IIMT Chu Spacelab (Mr

Roger Moldon)

2012/07/26GE Healthcare LLC Optima Mobile X-ray System (Optima XR200 15kw, Optima

XR 200 30kw, Optima XR 220 15kw, Optima XR 220 30kw)FDA Z-1993-2012 Class II

GE Medical Systems

Hong Kong Ltd.

2012/07/26Sigma SIGMA Spectrum Infusion Pump Master Drug Library (MDL) Editor

software (all versions)FDA Z-2030-2012 class III

Baxter Healthcare Ltd.

(Hong Kong)

2012/07/31A15130016

MHRA 2012/007/025/081/008 FSN N.A.

2012/07/31Molnlycke Health Care Barrier Extremity Drape 230x315cm

Product code: 60213-00 and batch no.: 12167258MHRA 2012/007/026/291/001 FSN N.A.

2012/07/31

Philips Healthcare Inc DigitalDiagnost, Essenta DR, Essenta DR compact,

BuckyDiagnost, EasyDiagnost Eleva and TraumaDiagnost using the 5-Field

Amplimat chamber

Serial no.: 11320067 to 11321695 and from 11322000 to 11322231

MHRA 2012/007/024/081/014 FSNPhilips Electronic Hong

Kong Ltd

2012/07/31Agfa HealthCare DRYSTAR DT2 MAMMO – REF: ERE5C and ERE6E;

DRYSTAR DT5.000I MAMMO – REF: EZ5J1 (LOT : 36130026 and 36130028)MHRA 2012/003/028/081/007 FSN

AGFA Hong Kong

Limited

2012/07/31Changzhou Zhiye Medical Devices Institute (supplied in UK by L.IN.C Medical

Systems) Pre-filled syringes of saline (LMPFSS) MHRA 2011/010/011/401/001 FSN N.A.

2012/07/31 Diamesco Co. Ltd. Pendiq Digital Insulin Pen (Software Version 1.07.0) MHRA 2012/007/018/081/005 FSNTwobiens Co., Ltd

(Korea)

2012/07/31Flexicare Medical Flexi- Lock Catheter Mount with Double Swivel Elbow and

Elastometric Cap [Part no.: 038-61-316 & lot no.: 110760229]MHRA 2012/002/022/401/014 FSN

Flexicare Medical China

Limited - China

2012/07/31 Elekta Inc. Digital Accelerator [Model no.:105071 to 105360] MHRA 2012/007/020/081/016 FSN Elekta Ltd

















Date of Issue

(YYYY/MM/D

D)



Alert Type by

SourceLocal Agent

2012/06/01

Beckman Coulter Inc. A) Beckman Coulter AU2700 Immunochemistry system -

Bicarbonate (CO2) Assay; B) Beckman Coulter AU5400 Immunochemistry

system - Bicarbonate (CO2) Assay; C) Beckman Coulter AU Immunochemistry

system - Bicarbonate (CO2) Assay


Kong Ltd

2012/06/01

Beckman Coulter Inc. A) Access Intrinsic Factor AB (for Unicel DXI 600 Access

Immunoassay System); B) Access Intrinsic Factor AB (for Access

Immunoassay System); C) Access Intrinsic Factor AB (for Unicel DXI 800

Access Immunoassay system)


Kong Ltd

2012/06/01GE Medical Systems SCS A) AW Volumeshare 2; B) Advantage Workstation

4.2; C) AW Volumshare 4; D) AW Volumeshare 4Health Canada 73642 Type III

GE Medical Systems

Hong Kong Ltd.

2012/06/01Nidek Medical Products Inc. Nidek Medical oxygen concentrator (Various

Models)FDA N.A. Class I

A) Medicare; B) Promed

(Tel : 2865 2938/ 9656

7063)

2012/06/01 Alere San Diego Triage Tropinin I Test Catalogue Number 98600EU Health Canada 74009 Type IIIPhilips Electronics

Hong Kong Ltd

2012/06/01 Philips Medical Systems (CLE) Inc. Brilliance iCT and iCT SP Health Canada 74087 Type II N.A.

2012/06/01 Immucor Inc. Capture-R Ready Indicator Red Cells Health Canada 74104 Type III Uninet Technology LTD

2012/06/01 Beckman Coulter Inc. SYNCHRON® System LX Calibrator 1 Health Canada 62306 Type IIBeckman Coulter Hong

Kong Ltd

2012/06/01Ortho-Clinical Diagnostics Inc. Vitros 5600 Integrated System - Software

Version 1.6 and belowHealth Canada 73912 Type II

Ortho Clinical

Diagnostics

2012/06/01 Roche Diagnostics GMBH AMPLINK Software Health Canada 73974 Type IIRoche Diagnostics

(Hong Kong) Ltd

2012/06/01

Varian Medical Systems A) Clinac Linear Accelerator

B) Clinac IX High Energy Linear Accelerator

C) Trilogy High Energy Linear Accelerator

D) Novalis TX High Energy Linear Accelerator

E) Clinac 2100C High Energy Linear Accelerator

F) Clinac 21EX High Energy Linear Accelerator

G) Clinac 23EX High Energy Linear Accelerator


Pacific Inc.

2012/06/01 Stryker Instruments IFU for Neptune Waste Management System Health Canada 74172 Type I Stryker China Ltd

2012/06/01

Beckman Coulter Inc. A) Navios Flow Cytometer (Navios 6 Colours / 2 Lasers)

B) Navios Flow Cytometer (Navios 8 Colours / 2 Lasers)

C) Navios Flow Cytometer (Navios 10 Colours / 3 Lasers)Health Canada 73958 Type III


Kong Ltd

2012/06/01Beckman Coulter Inc. Access Testosterone - Unicel DXC 600i Synchron

Access Clinical SystemsHealth Canada 73959 Type III


Kong Ltd

2012/06/01Beckman Coulter Inc. Unicel DXH Slidemaker Stainer Coulter Cellular Analysis

SystemHealth Canada 74006 Type III


Kong Ltd

Major Safety Alerts in June 2012



http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_apr-june_2012-eng.php














2012/06/01

Howmedica Osteonics Corporation A) Rejuvenate Modular Neck, 0 DEG

B) Rejuvenate Modular Neck, 8 DEG

C) Rejuvenate Modular Neck, 16 DEG

D) Rejuvenate SPT Modular Stem, Straight Press-Fit Texture TMFZ


2012/06/01 Bomimed Inc. Metal Led Disposable Conventional Blade Health Canada 73918 Type II N.A.

2012/06/01Varian Medical Systems, Inc. Eclipse Treatment Planning Sustem V8.8 EBP

issues (Model No. 100042024)Health Canada 73919 Type II


Pacific Inc.

2012/06/01Varian Medical Systems, Inc. Varian Treatment For Multivendor Linacs (Model

No.100042022)Health Canada 73925 Type II


Pacific Inc.

2012/06/01Varian Medical Systems, Inc. Eclipse Treatment Planning Sustem V8.8 (Model

No. 100042024)Health Canada 73926 Type II


Pacific Inc.

2012/06/01 Lightlab Imaging Inc. C7 Dragonfly Imaging Catheter (Model No. 100-100-00) Health Canada 73301 Type IIISt. Jude Medical (Hong

Kong) Ltd.

2012/06/01Linvatec Corporation DBA Conmed Linvatec 8.0 MM and 8.5 MM Sentinel Drill

Bit (Model No.: S8580, S8585)Health Canada 73513 Type II N.A.

2012/06/01Amvex Corporation Click Style Gas Regulators (Model No.: GR(X)X-YYY(Z)(W)-

(X)(Y)(Z)(W))Health Canada 73640 Type II N.A.

2012/06/01Beckman Coulter Inc Direct Bilirubin_OSR6111, OSR211, OSR6511 (all lot

number affected)Health Canada 73644 Type III


Kong Ltd

2012/06/01Lightlab Imaging Inc. A) CX-XR Imaging System, B) CX-XR Imaging System

(Model/Part no.: A) 900-700-10, B) 900-700-00)Health Canada 73295 Type III

St. Jude Medical (Hong

Kong) Ltd.

2012/06/01

Cardinal Health A) Custom Sterile Knee Pack, B) Custom Sterile

Vascular/Thoracotomy Pack, C) Custom Sterile Neurology Pack, D) Custom

Sterile Abdominal Hysterectomy Pack, E) Custom Sterile Pacemaker, F)

Orthopaedic Pack, G) General Sterile Pack, H) Custom Sterile Extremity Pack,

I ) Knee Packs, J) Urology Packs, K) Thoracotomy Pack, L) Custom Sterile

Craniotomy Pack, M) Custom Sterile Head and Neck Pack, N) Custom Sterile

Dental Pack, O) Custom Sterile Ear Pack, P) Custom Sterile Oral Pack, Q)

Custom Sterile Throat / Tonsil Pack, R) Custom Sterile General ENT Packs, S)

Custom Sterile Shoulder Pack, T) Custom Sterile General Gyne Pack, U)

Custom Sterile Laparotomy / Laparoscopy Packs, V) Custom Sterile Labour

and Delivery Pack, W) Laparotomy / Laparoscopy Packs, X) Facial Surgery

Packs, Y) General Plastic Surgery Packs, Z) Minor Surgery Packs, AA) Major

Surgery Packs, BB) Custom Sterile Abdominal Lithotomy Pack, CC) Sterile

Shoulder Arthroscopy Pack, DD) Sterile Total Hip Pack, EE) Sterile ACL Pack,

FF) EP Pack, GG) AV Fistula Graft, HH) Ortho Extremity Pack, II ) Craniofacial

Health Canada 73463 Type II Cardinal Health

2012/06/01Steris Corporation A) System 1 Express – Tray, B) System 1 Plus Tray

(Model/Part no.: A) C1XXXINT, B) C1XXXINT)Health Canada 73639 Type III

Swedish Trading Co.

Ltd.

2012/06/01Osteotech Inc. A) Grafton Gel, Putty and Flex; B) Grafton DBM Putty, Gel, Flex,

A-Flex, Crunch, Matrix PLF, Matrix Strips, Orthoblend, Grafton Plus DBM PasteHealth Canada 73678 Type II

Medtronic International

Ltd

2012/06/01Applied Medical Resources Corporation Surgical Clamp Inserts_G-

8655_1131182Health Canada 66075 Type III

Long Hin Medical

Limited/ Olympus Hong

Kong and China Limited

2012/06/01

Steris Mexico A) Evolution Transfer Carriage - AMSCO EVOLUTION

PREVACUUM STEAM STERILIZER; B) Evolution Transfer Carriage - AMSCO

EVOLUTION SFPP STEAM STERILIZER

Health Canada 73374 Type III N.A.

2012/06/01Pulse Scientific Inc. Rheumatoid Factor (RF) Latex Test (Model/Part no.:

10502, 10503)Health Canada 73646 Type III N.A.

2012/06/01 Wright Medical Technology Inc. Valor Targeting Guide (4150KIT1) Health Canada 73728 Type IIHong Kin Medical

Instrument Limited

2012/06/01 Immucor Inc. Galileo Echo Blood Bank Analyzer Cat No.: 87000 Health Canada 73948 Type III Uninet Technology LTD



















2012/06/01 Abbott Laboratories LtdAbbott

Laboratories Ltd.N.A. NA Abbott Laboratories Ltd.

2012/06/07 Sewoon Medical Co., Ltd. Fluido Junior Disposable Sets & Fluido Junior MHRA 2012/002/010/081/010 FSN N.A.

2012/06/07Smith & Nephew Orthopaedics Ltd Metal Liner Components of the R3

Acetabular systemMHRA 2012/006/006/291/023 FSN Smith & Nephew Ltd.

2012/06/07 Thermofisher Scientific MULTIGENT Hemoglobin A1c Reagent MHRA 2012/005/025/081/019 FSNThermo Fisher

Scientific (HK)

2012/06/07 BD Preset™ Arterial Blood Collection Syringe BD N.A. NA BD

2012/06/07 Perouse Medical Flamingo inflation device MHRA 2012/005/025/081/001 FSN N.A.

2012/06/07 Anaesthetic machines and associated devices MHRA MDA/2012/031 MDA N.A.

2012/06/07 Anetic Aid Ltd 6 Use Tourniquet Cuffs (Batch no.: 15435) MHRA 2012/005/004/401/005 FSN N.A.

2012/06/07 Aspen Medical Europe Ltd Procedure Kit [1672, 1674, 1650] MHRA 2012/005/029/601/003 FSN N.A.

2012/06/07Hitachi Medical Systems Echelon OASIS AIRIS Vento AIRIS Vento LT

APERTO Eterna APERTO LucentMHRA 2012/005/029/081/004 FSN

The Industrial

Promoting Co. Ltd.

2012/06/08

MOOG Non-DEHP Microbore or Admin Sets, Epidural Admin Sets (Model no:

340-4114, 340-4115, 340-4126, 340-4128, 340-4128-V, 340-4130, 340-4130-V,

340-4137, 340-4144, 340-4165, 340-4166, 340-4173, 340-4133, 340-4176)

FDA Z-1659-2012 to Z-1672-2012 Class IMoog Controls Hong

Kong Ltd.

2012/06/08

Siemens Medical Solutions USA, Inc Symbia E Series SPECT System [Material

number 10275879]; e.cam Emission Computed Tomography Systems [Material

number 10151532]; FDA Z-1686-2012 & Z-1687-2012 Class IISiemens Healthcare

Diagnostic Limited

2012/06/08 Invacare Corporation Knee walker FDA Z-1704-2012 Class II Direct Health Ltd.

2012/06/08Kerr Corporation Extrude Wash (Model no: 28418 – 2pk, 28419 – 32pk, 29036

– Value Pack)Synbron NA NA

Citicon (Hong Kong)

Limited

2012/06/11 Trinity Biotech CaptiaTM Varicella-Zoster Virus (VZV) IgG Kit

Tin Hang

Technology

Limited

NA NATin Hang Technology

Limited

2012/06/12Waters Corporation Waters Masstrak Immunosuppressants Kit (Part Number:

186002891, Lot.: 0709)MHRA 2012/005/029/081/001 FSN N.A.

2012/06/12Waters Corporation MassTrakTM Immunosuppressants Kit (Part Number:

186002891, 186004534 and 1860045331VD, all lots)MHRA 2012/005/029/081/036 FSN N.A.

2012/06/12

NEWDEAL SAS Drilling guide for diameter 3.5 mm screw

Instruments included in the following Newdeal instrumentation sets:

TIBIAXYS® Ankle Arthrodesis Plating System

TIBIAXYS® Distal Tibia and Fibula Osteotomy Plating Systems

ADVANSYS® Dorsal Lisfranc Plate / ADVANSYS® Medial Lisfranc Plate

MHRA 2012/006/006/291/027 FSN N.A.

2012/06/12Philips Healthcare DigitalDiagnost with Software Update 2.1.3 for 2.0.2 systems

including mirror iconMHRA 2012/006/006/291/072 FSN

Philips Electronics

Hong Kong Ltd.

2012/06/12Siemens Healthcare Diagnostics IMMULlTE/IMMULITE 1000 Total T3

Model/Part no.: LKT31, LKT35MHRA 2012/006/001/601/004 FSN

Siemens Healthcare

Diagnostic Limited

2012/06/12ArjoHuntleigh All models Minstrel, Minerva, Excelsior, Gemini patient lifts.

Manufactured by Medibo Medical Products NVMHRA 2012/006/007/291/072 FSN

Arjo Huntleigh (Hong

Kong) Ltd.

2012/06/12Ethicon Endo-Surgery Ligaclip Extra ligating clip cartridges (Product Code:

LT300)

Johnson &

Johnson (Hong

Kong) Ltd.

NA NAJohnson & Johnson

(Hong Kong) Ltd.

2012/06/12 Covidien Monoject TM Insulin Safety Syringe MHRA 2012/005/031/081/001 FSNCovidien Hong Kong

Limited









http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm307229.htm










2012/06/12Cordis Coporation CordisTM Fire Star Rx PTCA Dilation

Catheter_8012020D_15437344

Johnson &

Johnson (Hong

Kong) Ltd.

NA NAJohnson & Johnson

(Hong Kong) Ltd.

2012/06/15Roche Diagnostics GmbH Various tests with Cobas C701 Analyzer, Hitachi

Cobas C AnalyzersHealth Canada 74429 Type III

Roche Diagnostics

(Hong Kong) Ltd

2012/06/15 Vital Diagnostics ESR Altitude Vacuum Tubes Health Canada 69956 Type II N.A.

2012/06/15

Varian Medical Systems Inc. A) Aria Practice Management - 4D Integrated

Treatment Console (4DITC) Version 8.8 ; B) Barcode Conical Collimator

Verification (BCCV)


Pacific Inc.

2012/06/15Varian Medical Systems Inc. Multileaf Collimator (Model: Millenium 80, MLC 52;

Lot: H542182, H520320, H542533)Health Canada 74465 Type II


Pacific Inc.

2012/06/15 Varian Medical Systems Inc. Aria Software Vision (version 6.5) Health Canada 74474 Type IIVarian Medical Systems

Pacific Inc.

2012/06/15Terumo Cardiovascular Systems Corp. A) Sarns Flexible Arterial Cannula, B)

Sarns High Flow Aortic Arch Cannula Health Canada 74290 Type II

TERUMO CHINA (H.K.)

LTD.

2012/06/15 Medinol Ltd Digital Diagnost Health Canada 74401 Type II N.A.

2012/06/15 Kerr Corporation Permlastic Health Canada 73960 Type IIICiticon (Hong Kong)

Limited

2012/06/15(Model: 962-174, lot no.: C15B21)

Health Canada 73729 Type IIIRadiometer China

(RCHN)

2012/06/15Beckman Coulter Inc. Blood Bag Cup used in Model J6 Series Centrifuges (J6-


Kong Ltd

2012/06/15Beckman Coulter Inc. Immage Immunochemistry Systems Alpha1-Antitrypsin


Kong Ltd

2012/06/15One Lambda Inc. Micro SSP Allele Specific HLA Class II DNA Typing Tray -

Health Canada 66864 Type IIIMDSS GmbH

(Germany)

2012/06/15

Excelsior Medical Corporation A) Heparin Lock Flush (Model: 50031-1000,

50051-1000, 513604, 60031-1000, 60051-1000, E0400-35)

B) Heparein Lock Flush in Syringe (Model: 0300 31-240)


2012/06/18 Fake Thermometers MHRA N.A. Press Release N.A.

2012/06/19 Waters Corporation Waters Masstrak Immunosuppressants XE RUO Kit MHRA 2012/005/029/081/002 FSN N.A.

2012/06/19 (Model.: 6565-0-128 and lot no.: 35205901, 35205902, 35226701, 35226801,

35226801, 35544901)

MHRA 2012/006/007/291/069 FSN Stryker China Ltd

2012/06/19

Synergy Health (UK) Ltd Detex X-Ray Detectable Tied 5 Gauze Swab BP

(Model: a)28925(30x30 12Ply Taped), b)28925 (30x30 12 Ply no Tape) and lot

no.: a)289381312, b)289251312)MHRA 2012/006/007/601/004 FSN N.A.

2012/06/19 Sysmex Europe GmbH CS-2x00i Software Version 60 (V00-60) MHRA 2012/005/018/081/009 FSN Sysmex Hong Kong Ltd.

2012/06/19Arcadia Medical Corporation Arcadia Medical Silicone Tracheostomy Tubes (all

models, all types)MHRA 2012/006/007/601/003 FSN N.A.

2012/06/19Alba Bioscience ALBAclone Anti-P1 blood grouping reagent, Product code:

Z202, Lot: V112715MHRA 2012/006/006/601/005 FSN N.A.

2012/06/19

Biomet Merck Alumina Femoral Heads (Ref no.: P0209C28, P0209C32,

P0209L28, P0209L32, P0209M28, P0209M32; Affected lot no.: 2521085,

2522540, 2521086, 2557191, 2521087, 2532348)

MHRA 2012/006/012/081/004 FSN N.A.

2012/06/19CareFusion Airlife® Infant breathing circuits [Model no.: 6800-503 and RT 4851-

12]MHRA 2012/006/011/081/024 FSN


Ltd.

2012/06/19Mercado Medic AB Real 9000, Real 9300, Real 9700, Real 9000 Plus Manuel

Vuxen, Real 9300 Plus Manuell Barn, Real 9700 Plus CoxitMHRA 2012/006/006/291/003 FSN N.A.

2012/06/19Microbiologics Inc KWIK-QC Gram Stain Slides, SL03-10 SL03-10 [lot no.:

0353,0354,0355,0357,0358,0359,0360,0361,0362,0363]MHRA 2012/006/008/291/023 FSN N.A.














http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON155710











2012/06/19 Mindray V Series Monitor (Model: V12 & V21) MHRA 2012/006/008/291/030 FSNMR Holdings (HK)

Limited

2012/06/19Newdeal (Integra) HINTEGRA® tibial alignment rod ref. 309615 [ lot no.: EC13 -

EDD0/1 - EDD0/2 - EDD0/3 - EG6L – ELKG - ENZ0 - ELNS]MHRA 2012/006/007/291/045 FSN N.A.

2012/06/19Terumo Cardiovascular Systems Corp. A) Sarns Flexible Arterial Cannula, B)

Sarns High Flow Aortic Arch Cannula MHRA 2012/006/014/081/021 FSN

TERUMO CHINA (H.K.)

LTD.

2012/06/19 Philips Healthcare IntelliSpace Portal (ISP)_Software versions: v4.0 or v4.0.1 MHRA 2012/006/011/291/006 FSNPhilips Electronics

Hong Kong Ltd

2012/06/19Siemens Healthcare Diagnostics Stratus CS Acute Care™ D-Dimer CalPak

Calibrator (CDDMR-C)_Affected lot no.: 502058002 and 501318002MHRA 2012/006/008/601/005 FSN

Siemens Healthcare

Diagnostic Limited

2012/06/21GE Medical Systems Revolution XR/d Model numbers: 2259988-2 & 2351505,

Definium 8000 Model Number: 5131070, Proteus XR/a Model Number: FDA Z-1788-2012 to Z-1790-2012 Class II

GE Medical Systems

Hong Kong Ltd.

2012/06/21

Integra Lifesciences Corporation A) Integra Mozaik Strip 10 cc [Part Number

7701513001]; B) Integra Mozaik Putty 2.5cc, 5 cc, 10 cc [Part Number

7700713001]

FDA Z-1795-2012 & Z-1796-2012 Class II N.A.

2012/06/21Stryker Instruments A) T5 Hytrel Zipper Toga; B) T4 Hytrel Zipper Toga

[Various lots]FDA Z-1809-2012 & Z-1810-2012 Class II Stryker China Ltd

2012/06/22

Terumo CVS A) Terumo Advanced Perfusion System 1

B) Sarns™ Modular Perfusion System 8000,

C) Sarns™ Modular Perfusion System 9000

TERUMO

CHINA (H.K.)

LTD.

A) AA-2012-003-C-Sys1

B) AA-2012-003-C-8000

C) AA-2012-003-C-9000NA

TERUMO CHINA (H.K.)

LTD.

2012/06/22 Brainlab Brainlab iPlan RT Dose version 4.1 (v.4.1.0, 4.1.1 and 4.1.2) Brainlab Ltd 12-04-17.FRM.2 NA BrainLAB Ltd

2012/06/26 Sekisui Diagnostics Multigent Acetaminophen Assay Health Canada 75088 Type I N.A.

2012/06/26 Conmed Altrus Thermal Tissue Fusion Energy Source Health Canada 73980 Type II N.A.

2012/06/26 Winco Winco Carecliners Health Canada 74174 Type II N.A.

2012/06/26 Abbott Diagnostics Ltd Multigent - Aeroset/C8000 Hemoglobin A1C Kit Health Canada 74545 Type II Abbott Laboratories Ltd.

2012/06/26Sybron Dental Specialities AlgiNot Cartridge, AlgiNot Cartridge FS, AlgiNot

Volume, AlgiNot Volume FS

Sybron Dental

SpecialitiesN.A. FSN Citicon (Hong Kong) Ltd

2012/06/26 Biomerieux BV Bact/Alert MB Blood Culture Bottle Health Canada 74178 Type II bioMerieux China Ltd.

2012/06/26

GE

Ohmeda Medical, a Division of Datex Ohmeda Inc A) Giraffe Warmer T-Piece

Resuscitation Circuits, B) Panda Warmer T-Piece Resuscitation Circuits


Hong Kong Ltd.

2012/06/26 Boston Scientific Zoom Latitude Programmer/Recorder/Monitor-3120 Health Canada 71308 Type II Boston Scientific

2012/06/26 Invacare Corporation Power Wheelchair Health Canada 75032 Type II Direct Health Ltd.

2012/06/26

Philips Medical Systems A) Multidoagnost Eleva-Image Intensifier-TV Image

Detector, B) Multidiagnost Eleva-Flat Detector-Image Detector Health Canada 75028 Type IIPhilips Electronics

Hong Kong Ltd

2012/06/26Stryker Medical A) Go Bed Plus FL25E, B) Go Bed II, C) Go Bed Plus FL20E


2012/06/26 Asahi Kasei Medical Blood Purification Equipment PlasautoΣ MHRA 2012/006/018/081/005 FSN N.A.

2012/06/26Carestream Health CARESTREAM DRX-1 System Batteries manufactured

before June 2012MHRA 2012/006/021/081/009 FSN N.A.

2012/06/26 DiaMed/ BioRad Techno TwinStation, Product ref.: 009895 MHRA 2012/006/021/081/014 FSN N.A.

2012/06/26Fresenius Medical Care DALI 500 (REF 9798201), DALI 750 (REF 9798211),

DALI 1000 (REF 9798221), DALI 1250 (REF 9798241) KitMHRA 2012/002/008/081/025 FSN N.A.

2012/06/26Liko AB Liko® FreeSpan™ Traverse and FreeSpan Ultra Twin™ Traverse,

3EN110750-01 thru – 04, shipped prior to November 2007MHRA 2012/006/015/081/022 FSN N.A.

2012/06/26Teleflex Medical ConchaTherm Neptune Heated Humidifiers (Product codes:

425-00, 425-10, 425-30)MHRA 2012/006/019/291/001 FSN N.A.

2012/06/26 Transysteme AES Ankle prosthesis MHRA 2011/012/021/291/018 FSN N.A.

2012/06/26Kerr Corporation Alginot FS Volume Refill Kit (Model/Part no.: 34683, 34682;

Affected lot number: 1‐1017)Health Canada 72943 type II N.A.



























2012/06/26 St. Jude Medical Merlin@Home Transmitter Health Canada 74553 type IIISt. Jude Medical (Hong

Kong) Ltd.

2012/06/27 Sunquest Information Systems Sunquest Laboratory Health Canada 75100 Type III N.A.

2012/06/27Howmedica Osteonics Corporation A) Austin Moore Hip Endoprosthesis

B) Trident PSL HA Solid Back Acetabular ShellHealth Canada 75048 Type III Stryker China Ltd

2012/06/27 GE Medical Systems LLC Discovery CT750 HD (Model no.: 5212920-X) Health Canada 74848 Type IIIGE Medical Systems

Hong Kong Ltd.

2012/06/27Smiths Medical ASD Inc A) CADD-PCA Ambulatory Infusion Pump

B) CADD-Plus Ambulatory Infusion PumpHealth Canada 73890 Type III

Goodman Medical

Supplies Ltd

2012/06/27 Gen-Probe GTI Diagnostics Lifecodes Pak Plus 022811PPB Health Canada 73292 Type III bioMerieux China Ltd.

2012/06/27International Technidyne Corporation ProTime Microcoagulation System-

Protimepro V-71458Health Canada 74886 Type III N.A.

2012/06/27 Ormco Corporation, also trading as Sybronendo K-Flex Files Health Canada 74286 Type IIISybron Dental

Specialties

2012/06/276602764, 6603152 & Affected serial no.: 7125011K, 7087007K, 7125012K,

7087008K)Health Canada 74549 Type III


Kong Ltd

2012/06/27 Health Canada 74849 Type IIIGE Medical Systems

Hong Kong Ltd.

2012/06/27Covidien A) Kangaroo 324 Enternal Feeding Pump, B) Kangaroo 224 Enteral

Feeding Pump RefurbishedHealth Canada 74862 Type III

Covidien Hong Kong

Limited

2012/06/27Beckman Coulter Inc. Synchron Systems Modular Phosphorus (PHOSM)

Reagent (Model no.: 467868; lot no.: M108021, M110381, M109034, M112164, Health Canada 74551 Type III


Kong Ltd

2012/06/27Beckman Coulter Inc. Synchron Systems Total Protein (TP) Cartridge Reagent

for use on DXC Systems (Model no.: 442740; lot no.: all)Health Canada 74552 Type III


Kong Ltd

2012/06/27GE Medical Systems A) Optima XR220AMX X-Ray System; B) Optima

XR220AMX X-Ray System - Main UnitHealth Canada 74838 Type III

GE Medical Systems

Hong Kong Ltd.

2012/06/28Fresenius Medical Care Naturalyte Liquid Acid Concentrate and Naturalyte

GranuFlo (powder) Acid ConcentrateFDA Z-1826-2012 Class I

Fresenius Medical Care

Hong Kong Ltd.

2012/06/28 GE Healthcare GE Healthcare, Aestiva/5 7900 SmartVent" FDA Z-1787-2012 Class IGE Medical Systems

Hong Kong Ltd.

2012/06/28code : 5135 and Affected lot no.: B6Z4K)


2012/06/28

Tripath Imaging, Inc. A) PrepStain Syringing Pipettes 240; B) PrepStain GYN

480 Disposable Test Kit with PreCoat Slides; C) PrepStain Installation Kit

(PreCoat); D) Manual Method 1: 480 Test Kit (PreCoat); E) PrepStain GN 480

Disposable Kit (Model/Catalog no.: A) 490517; B) 490523; C) 490528; D)

FDA

Event ID: 61737; Recall

number: Z-1811-2012 to Z-

1815-2012

class IIIBecton Dickinson Asia

Limited (BD)

2012/06/29 Reusable transoesophageal echocardiography, transvaginal and transrectal

ultrasound probes (transducers)MHRA MDA/2012/037 MDA N.A.

2012/06/29 Invacare All Birdie and Flamingo mobile patient hoist carabiners MHRA MDA/2012/038 MDA Direct Health Ltd.





















Date of Issue

(YYYY/MM/D

D)



Alert Type by

SourceLocal Agent

2012/05/02St. Jude Medical Brio™ (Deep Brain Stimulator), Product Code: 65-6788,

Affected lot number: up to 13854243MHRA 2012/003/027/081/027 FSN


Kong) Ltd.

2012/05/02HSIN Ten Enterprise Electro Reflex Energizer, Product Code: SR001A2,

Affected lot number: from 828015484 to 828015813Health Canada 73289 Type III N.A.

2012/05/02Terumo Spectra Optia® Apheresis System, all Serial Numbers with Software

Version 5 or higherMHRA 2011/005/025/401/004 FSN

Terumo China (Hong

Kong) Ltd.

2012/05/02Topcon Medical Laser Systems Topcon PASCAL and PASCAL Streamline,

2RG Sofrware v2.01 Endpoint Management EnableMHRA 2012/004/024/081/016 FSN N.A.

2012/05/02Nobel Biocare AB 30 Degree Multi-Unit Abutment Nobelactive Int RP 3.5mm,

Model no.: 34369, Lot no.: 464886Health Canada 72651 Type III Nobel Biocare Asia Ltd.

2012/05/02 Maquet Magnus Carbon Fibre Table Top, model no.: 1180.16F5 Health Canada 72980 Type IIIMAQUET Hong Kong

Limited

2012/05/02Philips Medical Systems Brilliance 64 Slice CT System - Main Unit, Model no.:

4550 110 00921Health Canada 72982 Type III

Philips Electronics

Hong Kong Ltd

2012/05/02

Vapotherm A) Insolare Nasal Cannula (Infant), Imi1300

B) Insolare Nasal Cannula (Intermediate Infant), Imi1300B

C) Insolare Nasal Cannula (Premature), Imn1100A

D) Insolare Nasal Cannula (Neonatal), Imn1100B

E) Single Prong Nasal Cannula (Infant), Isolo1300


2012/05/02Beckman Coulter Access Total T4 Reagent (Access System, Dxi 600 System

and Dxi 800 System) Model no: 33800Health Canada 73246 Type III


Kong Ltd

2012/05/02Beckman Coulter Beckman Coulter AU2700, AU5400 and Immunochemistry

System - Urinary/CSF Protein Assay, Model no.: OSR6170, OSR6270Health Canada 73302 Type III


Kong Ltd

2012/05/02 Wright Medical Technology Inc. Dynasty Biofoam Shell Health Canada 72874 Type IIHong Kin Medical

Instrument Limited

2012/05/02Invacare Corporation TDX SP Power Wheelchair [Model No.: TDXSP-CG,

TDXSP-CG-GT, TDXSP-MCG, TDXSP--MCG-GT]Health Canada 72976 Type II Direct Health Ltd.

2012/05/02

Carefusion 209, Inc. DBA Carefusion A) Nicolet EDX System Software [Model

No.: 828-050000, 828-062900] version 2.9.2; B) Nicolet EEG Software [Model

No.: 828-063500, 828-063600] version 2.9.2

Health Canada 71318 Type IICareFusion Hong Kong

Ltd.

2012/05/02

Zimmer Inc. A) Nexgen Complete Knee Solution - CR (Cruciate Retaining)

Articular Surface; B) Nexgen Complete Knee Solution - Articular Surface

Anterior Constrained; C) Crosslinked Polyethylene Articular Surfaces - A-B/3-4

Striped Yellow; D) Crosslinked Polyethylene Articular Surfaces - A-B/1-2 Purple

Health Canada 72851 Type IIZimmer PTE Ltd. (Hong

Kong branch)

2012/05/02Cordis (a Johnson & Johnson company) Cordis S.M.A.R.T. Transhepatic Biliary

StentHealth Canada 73373 Type II

Johnson & Johnson

(Hong Kong) Ltd

2012/05/02 Kerr Corporation Freedom Cordless LED Headlight Health Canada 72749 Type II N.A.

2012/05/02 Ormco Corporation Arch Hooks Health Canada 72992 Type IISybron Dental

Specialties

2012/05/02 Innovatek Medical Inc BioStrip LH Ovulation Test Health Canada 72936 Type II N.A.

2012/05/02BioRad/ DiaMed GmbH IH-Com Full kit version (Data Management and Result

Interpretation Software) (Product Ref: 009000)MHRA 2012/004/023/291/009 FSN Bio-Rad Pacific Ltd.

2012/05/02 Doctors Research Group Kryptonite Bone Cement® MHRA 2012/004/024/081/008 FSN N.A.

2012/05/02Dr Arabin GmbH & Co.KG Cerclage Pessaries Type ASQ (perforated),

Model/Part no.: ASQ 70/21/35, Affected lot no.: W 33/11/2MHRA 2012/004/023/291/001 FSN N.A.

Major Safety Alerts in May 2012
























2012/05/02 Ethicon Products PDS® Cord, and PDS® Cord II MHRA 2012/004/024/601/002 FSNJohnson & Johnson

(Hong Kong) Ltd.

2012/05/02Fannin NI Ltd LIP W11183 Legionella Medium + BCYE Growth Supplement

(Affected lot no.: 1463779807)MHRA 2012/004/013/081/024 FSN N.A.

2012/05/02 Life Technologies Corporation SeCore GSSP Set MHRA 2012/004/023/291/005 FSNInvitrogen Hong Kong

Limited

2012/05/02 Orascoptic Laser Loupes (shipped since 2008) MHRA 2012/004/020/291/015 FSN N.A.

2012/05/02Philips Healthcare Easy Diagnost Eleva DRF, System code.: 706037 (all

EasyDiagnost 4.0 with either one or two detectors)MHRA 12/004/017/081/023 FSN

Philips Electronics

Hong Kong Ltd

2012/05/02Philips Healthcare HeartStart MRx monitor/defibrillators, Model/ Part no.:

M3536A with software versions, R.01.00, R.02.00 and R.03.01MHRA 2012/004/024/081/014 FSN

Philips Electronics

Hong Kong Ltd

2012/05/02 Siemens Healthcare Diagnostics ADVIA Centaur® HCV kit (Ref no. 03438099) MHRA 12/004/025/601/002 FSNSiemens Healthcare

Diagnostic Limited

2012/05/03 Elekta XVI (X-Ray Volume Imaging system) R4.5 Elekta Ltd 200 01 507 047 FSN Elekta Ltd

2012/05/04 Hill-Rom Affinity Four Birthing BedSolar-Med

LimitedMod 471 FSN Solar-Med Limited

2012/05/08 Advanced Sterilization Products

Johnson &

Johnson Medical

(HK)

N.A. FSNJohnson & Johnson

Medical (HK)

2012/05/09

Hager & Werken GmbH & Co. KG Brilliant—Mouth mirror No.4 [Model no.:

605400 Lot no: MD-4/31] MHRA 2012/004/003/401/013 FSN N.A.

2012/05/09 Jenx Headrest brackets MHRA 2012/003/027/601/007 FSN N.A.

2012/05/09 Mast Group Cephalexin 30ug Cartridges Discs [CFX30C; Lot no: 298700] MHRA 2012/005/001/601/012 FSN N.A.

2012/05/09McKesson Medical Imaging Company Horizon Medical Imaging (HMI) [versions

11.5, 11.5.1, 11.5.2, 11.6, 11.7 and 11.8]MHRA 2012/004/013/081/006 FSN N.A.

2012/05/09 Water Pik Inc SinuSense™ Water Pulsator nasal irrigation devices FDA N.A.Firm Press

ReleaseN.A.

2012/05/09Zimmer NexGen PRI Femoral and Provisional Impactor/Extractor (00-5901-026-

00) and the replacement jaw assembly (00-5901-026-40)MHRA 2012/005/003/081/001 FSN

Zimmer PTE Ltd. (Hong

Kong branch)

2012/05/09Ceraver CERAPLUG, all batches sizes 1 to 6, references 4501-4502-4503-

4504-4505-4507MHRA 2012/004/020/291/024 FSN N.A.

2012/05/09Computerized Medical Systems (CMS) XiO Release 4.30, Reference no.:

33941MHRA 2012/005/003/081/007 FSN Elekta Ltd

2012/05/09Ortho-Clinical Diagnostics Inc. Vitros® 5600 integrated system software version

1.6 and belowMHRA

2012/004/030/601/002 Ortho Clinical

Diagnostics

2012/05/09Plasma Surgical Ltd Single Use Handpieces for the PlasmaJet® Neutral

Plasma Surgery SystemMHRA 2012/004/027/601/009 N.A.

2012/05/10 Endoscope accessory holder- all manufacturers MHRA MDA/2012/024 MDA N.A.

2012/05/11 Liberation treatment for multiple sclerosis FDA N.A. Press Release N.A.

2012/05/14 Terumo CVS Sarns™ Antegrade Cardioplegia Cannula Firm initiated AA-2012-007-R NATERUMO CHINA (H.K.)

LTD.

2012/05/15Wassenburg Medical Devices Wassenburg Automatic Endoscope Reprocessor

(Model no. WD440 & WD440PT)MHRA 2012/003/021/401/014 FSN N.A.

2012/05/15

Sigma International General Medical Apparatus Spectrum Infusion Pump with

Master Drug Library - Sigma Spectrum MDL Editor Software, 'MDL Editor

Software v6.2.4

Health Canada 73493 Type IIIBaxter Healthcare Ltd.

(Hong Kong)

2012/05/15 BioHorizon Implant Systems BioHorizons 0.050 One-Piece Hex Driver Health Canada 73517 Type III N.A.

2012/05/15 BioMet 3i Incise Coping CBZR0102 Health Canada 72143 Type III N.A.

2012/05/15Steris A) Steris 5085 Surgical Table

B) Steris 5085SRT Surgical TableHealth Canada 73453 Type III N.A.



















http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm303538.htm


http://www.hc-sc.gc.ca/dhp-mps/alt_formats/xls/compli-conform/recall-retrait/list/md-im_recalls-retrait_apr-june_2012-eng.xls




2012/05/15Roche Diagnostics A) Reduced On-Board Stability Sample Cleaner 1

B) Reduced On-Board Stability Sample Cleaner 2Health Canada 73305 Type III

Roche Diagnostics

(Hong Kong) Ltd

2012/05/15Kensey Nash Corp Collagen Dental Membrane [Model No.: 20650-01, 20650-

02, 20650-03]Health Canada 72842 Type I N.A.

2012/05/15Terumo CVS Cardiovascular Procedure Kit (X-Coated Perfusion Pack) [Model

No.: 73673, 73679]Health Canada 73480 Type I

TERUMO CHINA (H.K.)

LTD.

2012/05/15GE Healthcare (Japan Corporation) Discovery Magnetic Resonance Imaging

[Discovery MR750W 3.0T]Health Canada 73368 Type II

GE Medical Systems

Hong Kong Ltd.

2012/05/15

Shimadzu Corporation A) Mobile X-Ray System Mobile DaRt Evolution and

RAD Speed

B) Digital Radiography CXDI Wireless


2012/05/15

Bomimed Inc A) RespondPRO Adult and Child Resusitator - Feather Flex

Disposable Manual Resusiators; B) RespondPRO Adult and Child Resusitator -

Disposable Resuscitator

Health Canada 73105 Type II Bomimed Inc

2012/05/15

Berchtold Medizin-Elektronik GMBH Operon Surgical Table Model D850

(Affected lot no.: 3501110-S10032, 3501110-S10040, 3501110-S10074,

3501110-S10075, 3501110-S10077, 3501110-S10145, 3501110-S10270)


2012/05/15Roche Diagnostics GmbH A) Salicylate for Roche Cobas Integra, c311, c501,

and c502; B) Salicylate for Roche Cobas Integra, c311, c501, and c502Health Canada 73276 Type III

Roche Diagnostics

(Hong Kong) Ltd

2012/05/15

Roche Diagnostics GmbH A) Cobas Integra C-Reactive Protein

(Latex)(CRPL2) Appl. for C.F.A.S. B) Cobas Integra C-Reactive Protein (Latex)

High Sensitive (CRPHS) C) 24K Irrigation System - Remote Control D) Cobas

C-111 C-Reactive Protein (High Sensitive Assay) E) C-Reactive Protein Gen.3

(CRPL3) F) Hitachi Tina-Quant C-Reative Protein(Latex) High Sensitive Assay

(CRP) G) CRPL3 (C-Reactive Protein Gen. 3) for Cobas C701 Analyzer H)

CRPHS (Cardiac C-Reactive Protein (Latex) High Sensitive)

Health Canada 73277 Type IIIRoche Diagnostics

(Hong Kong) Ltd

2012/05/15Baxter Healthcare SA Baxter pump compatible blood set (Product code: VMC-

9609, Affected Lot no: 11K21V628)MHRA 2012/005/009/291/018 FSN Baxter Healthcare Ltd

2012/05/15 Becton Dickinson BD Gram Crystal Violet 250ml and BD Gram Stain Kit MHRA 2012/005/009/291/015 FSN BD

2012/05/15 DePuy (a Johnson & Johnson company) DePuy DeltaMotion Acetabular Cup MHRA 2012/005/009/081/021 FSNJohnson & Johnson

Medical (HK)

2012/05/15 Mini Crosser A/S Mini Crosser M1 scooters produced before 14/12-2010 MHRA 2011/012/012/081/003 FSN N.A.

2012/05/15PaloDEx Group Oy/ Instrumentarium Dental Instrumentarium OP-300 (Model:

1.14 and 1.15)MHRA 2012/005/002/081/014 FSN N.A.

2012/05/15Siemens Healthcare Diagnostics LabPro V4.11 (Compact Disc part no.: 9800-

3900, 9800-3906 or 9800-3918)MHRA 2012/005/008/601/004 FSN

Siemens Healthcare

Diagnostic Limited

2012/05/16DePuy (a Johnson & Johnson company) Side Fire Needle, part of Confidence

Spinal Cement SystemFirm initiated N.A. NA

Johnson & Johnson

Medical (HK)

2012/05/17 Ormco Corporation Enlight UnidoseSybron Dental

SpecialitiesNA NA

Sybron Dental

Specialties

2012/05/17 Endeavour Industries Pty Ltd Quad (4 X Point) Walking Stick TGA N.A. Alerts N.A.

2012/05/17Varian Medical Systems TrueBeam and TrueBeam STx Versions 1.0 through

1.5

Varian Medical

SystemsCP-07227 NA N.A.

2012/05/18 Clever Chek blood glucose monitoring system. MHRA MDA/2012/027 MDA

TaiDoc Technology

Corporation (distributed

by BBI Healthcare)

2012/05/18Biomet Troch Nail, Long 11MM, Right 34 CM Peritrochanteric Nail System

(Model no.: 28234)FDA Z-1478-2012 Class II N.A.

2012/05/18

Siemens Medical System Siemens-branded linear accelerator with a 550 TxT

Treatment Table with a. Siemens brand ARTISTE, ONCOR and PRIMUS

Linear Accelerator systems include the 550 TxT" Treatment Table.

FDA Z-1486-2012 Class IISiemens Healthcare

Diagnostic Limited
















http://www.tga.gov.au/safety/alerts-device-quad-walking-stick-120517.htm




2012/05/18Alere 1) Alere Triage CardioProfiler Panel PN 97100CP; 2) Alere Triage Profiler

SOB Panel, PN 97300FDA Z-1466-2012 to Z-1467-2012 Class II N.A.

2012/05/18Siemens Medical System ARTISTE or ONCOR Linear Accelerators in

combination with 160MLC (Multi Leaf Collimator)FDA Z-1493-2012 Class II

Siemens Healthcare

Diagnostic Limited

2012/05/18GF Health Products LUMEX A Graham-Field Brand, Bed End Sert. Low/Full-

electric, Plastic PanelsFDA Z-1536-2012 Class II N.A.

2012/05/18 Covidien Roticulator Single Use StaplerCovidien Hong

Kong LtdN.A. NA

Covidien Hong Kong

Ltd

2012/05/21

Abbott Molecular Inc. Vysis FISH Pretreatment Reagent Kit, [List # 02J03-032];

Vysis Paraffin Pretreatment Reagent Kit, [List# 02J02-032];

Paraffin Pretreatment Reagent Kit II, [List# 07J02-002]; Protease I, 250mg x2,

[List# 02J08-032];

Abbott Molecular

IncN.A. NA Abbott Laboratories Ltd.

2012/05/21 Boston Scientific Boston Scientific Profile™ Single-Use Pediatric Snares Boston Scientific 90765080-FA (AB) NA Boston Scientific

2012/05/22Airox SA (Covidien) Legendair™ Single Branch, Legendair™ Double Branch

and Supportair™MHRA 2012/003/030/081/015 FSN

Covidien Hong Kong

Limited

2012/05/22 Synthes Minimally Invasive Reduction Screw (MIRS) MHRA 2012/005/009/081/015 FSNSynthes (Hong Kong)

Ltd2012/05/22 Medica- Europe MERCI and MERCI-L (Articles 2618050 and 2618040) MHRA 2012/005/011/081/001 FSN Medica- Europe

2012/05/22Philips Medical Systems (CLE) Inc. Brilliance iCT and iCT SP (Cooling Unit

Welding Joint Detaches)MHRA 2012/005/011/081/008 FSN

Philips Electronics

Hong Kong Ltd

2012/05/22Siemens ACUSON S1000 ultrasound systems - 10441701, and the Advanced

SieClear spatial compounding featureMHRA 2012/005/014/291/024 FSN

Siemens Healthcare

Diagnostic Limited

2012/05/22Siemens ACUSON S2000 ultrasound systems - 10041461, 10440017, and the

Advanced SieClear spatial compounding featureMHRA 2012/005/014/291/019 FSN

Siemens Healthcare

Diagnostic Limited

2012/05/22 ArjoHuntleigh Encore, Chorus and Sara Plus Standing Aids MHRA 2012/004/012/401/008 FSNArjo Huntleigh (Hong

Kong) Ltd.

2012/05/22 Arrow International ARROWg+ard Blue® , ARROWg+ard Blue® Plus MHRA 2012/005/016/081/004 FSNCemma Enterprise Co.,

Ltd

2012/05/22 Fujifilm Europe QuickGene DNA whole blood kit S CE IVD MHRA 2012/005/014/291/014 FSN N.A.

2012/05/22 Schiller Medical FRED easy defibrillators & FRED easy Life defibrillators MHRA 2012/005/011/081/009 FSNa) Ultronics Enterprises

Ltd; b)Lynx Tech

2012/05/23

Biocompatibles UK Ltd Bead Block [Model no.: EB2S305, EB2S709, EB2S912;

Affected lot no.: S10348, S10355, S01345, S10347] Firm initiated FSCA 11-05-2012 NAPacific Medical (Hong

Kong) Co. Ltd.

2012/05/24 MOOG Curlin Intravenous Administration Sets FDA N.A.Firm Press

Release

Moog Controls Hong

Kong Ltd.

2012/05/25 Varian True Beam versions 1.0, 1.5.12.0 and below, 1.6.9.5 and below FDA Z-1495-2012 Class IIVarian Medical Systems

Pacific Inc.

2012/05/25 Caridian BCT COBE Spectra System Blood Warmer (Part no.: 950000000) FDA Z-1504-2012 Class IITerumo BCT (Hong

Kong) Ltd.

2012/05/25DeRoyal DeRoyal Sterile wound closure strips, sterile surgical kits containing

Episeal products and Non-sterile wound closure stripsFDA Z-1421-2012 to Z-1423-2012 Class II N.A.

2012/05/25 Leica Biosystems Nussloch Gmbh Vacuum Tissue Processor, Model ASP6025 FDA Z-1473-2012 Class II Leica Microsystems Ltd.

2012/05/25 Sandhill Scientific Inc. Insight rev H software FDA Z-1487-2012 Class II Sandhill Scientific Inc.

2012/05/25SenDx Medical Inc ABL80FLEX Blood Gas, pH, Electrolyte, and Metabolite

SystemFDA Z-1384-2012 Class II SenDx Medical Inc

2012/05/25 Capatex Medical Neonatal endotracheal tube SCP clamp/holder MHRA MDA/2012/029 FSN N.A.

2012/05/28 Baxa Corporation Abacus Total Parenteral Nutrition (TPN) Calculation Software FDA N.A. Class I JASPO Limited

2012/05/29Spacelabs Healthcare Spacelabs Healthcare Pathfinder SL Holter Analyzer,

version 1.6.0MHRA 2012/005/023/081/003 FSN

Schmidt Bio Med Tech

(H.K.)

2012/05/29 SmitCare SmitCare DreamMaster Light Mattress Elevator, Model no. DM300 MHRA 2012/005/022/601/001 FSN N.A.

2012/05/29 Siemens AG Siemens syngo RT Therapist Version 4.2 MHRA 2012/005/022/081/020 FSNSiemens Healthcare

Diagnostic Limited






















http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm305744.htm




2012/05/29

Siemens Healthcare Diagnostics ADVIA® 1200, ADVIA 1650, ADVIA 1800,

and ADVIA 2400 Chemistry Systems, Alkaline Phosphatase (ALPAMP and

ALPDEA): Reagent Kit Lots


Diagnostic Limited

2012/05/29 Atom Medical International Inc Dual Incu I, model number 100 MHRA 2012/005/021/007 FSN Long Hin Medical Ltd

2012/05/29

Edwards Life Sciences Inc Carpentier-Edwards PERIMOUNT Models 2900,

6900P, and 6900PTFX, Carpentier-Edwards PERIMOUNT Magna Models 3000

and 3000TFX, Carpentier-Edwards PERIMOUNT Magna Ease Model

3300TFX, Carpentier-Edwards PERIMOUNT Magna Mitral Model 7000TFX,

Carpentier-Edwards PERIMOUNT Magna Mitral Ease Model 7300TFX

MHRA 2012/005/021/081/005 FSNGoodman Medical

Supplies Ltd.

2012/05/29 Expanding Orthopedics Inc. XPED Expanding Pedicle Screw System MHRA 2012/005/015/081/002 FSN N.A.

2012/05/29

Heine Optotechnik GMBH HEINE Standard F.O. Laryngoscope Handle with

LED illumination [REF F-008.22.890 & S/N: 1230000000 and 1230999999] MHRA 2012/005/022/081/014 FSN

The Vita Company Ltd.

& Efficiency Medical

Products Co. Ltd.

2012/05/29 Natus Medical Incorporated Olympic Cool-Cap System - 60010 MHRA 2012/005/022/291/018 FSN N.A.

2012/05/29M.I. Tech Stent introducer for biliary endoscopic application, diameter 7 Fr, For

SHS stent range diameter 10 mm length 4 cm, 6 cm, 8 cm, 10 cmMHRA 2012/005/017/081/004 FSN N.A.

2012/05/29Philips Healthcare Computed tomography. Brilliance iCT and iCT SP software

version numbers 3.2.0, 3.2.1 or 3.2.3MHRA 2012/005/022/081/013 FSN

Philips Electronics

Hong Kong Ltd.

2012/05/29 Proact Medical LTD Metal Max 90 Laryngoscope Blade MHRA 2012/005/021/601/007 FSN N.A.

2012/05/30 Edwards LifesciencesEdwards

LifesciencesN.A. NA

Goodman Medical

Supplies Ltd.

2012/05/31 Terumo CVS Sarns Modular Perfusion System 8000 FDA Z-1450-2012 to Z-1453-2012 Class IITERUMO CHINA (H.K.)

LTD.

2012/05/31 Zimmer Zimmer Dental Trabecular Metal Implant FDA Z-1510-2012 to Z-1515-2012 Class IIZimmer PTE Ltd. (Hong

Kong branch)

2012/05/31Philips Medical Systems Practix Convenio Mobile X-ray System, Serial no.:

PC1-0504 through PC1-0588

Philips

Electronics HK

Ltd

FSN MA-FCO 70400049 FSNPhilips Electronics

Hong Kong Ltd

2012/05/31Siemens Healthcare Diagnostics Siemens ADVIA Centaur Vitamin D Diluent 2-

pack, Reference 10494100FDA Z-1268-2012 Class II

Siemens Healthcare

Diagnostic Limited

2012/05/31 Codman & Shurtleff Codman ICP Skull Bolt Kit, Product Code: 82-6638 FDA Z-1279-2012 Class IIJohnson & Johnson

Medical (HK)














Date of Issue

(YYYY/MM/D

D)



Alert Type by

SourceLocal Agent

2012/04/03 Philips Healthcare Brilliance 64 or Ingenuity CT with Software Version 3.5.1 MHRA 2012/003/027/081/018 FSNPhilips Electronics

Hong Kong Ltd

2012/04/03Welch Allyn VSM 200 & 300 series, SPOT Vital Signs, SPOT Lxi Power Cords

& TransformersMHRA 2012/001/011/401/014 FSN N.A.

2012/04/03 Wescott Medical Limited Weflow3 Hi-Flo Irrigation Set MHRA 2012/003/023/601/004 FSN N.A.

2012/04/03

Concateno FirstStep hCG Pregnancy Test (FHC-300) [Model/Part no.: FHC-

300; Affected lot no.: All lot numbers] MHRA 2012/003/022/081/001 FSN Concateno

2012/04/03 GBUK Healthcare TenderTip 24 & 72 Hour Closed Suction MHRA 2012/003/021/601/001 FSN GBUK Healthcare

2012/04/03Meditech Systems Ltd 22X150S X-tendable catheter mount + elbow [Affected

lot no: S21121101 & L09111108]MHRA 2012/002/007/601/004 FSN Meditech Systems Ltd

2012/04/03 Merck Serono Merck Serono auto-injector Easypod™ MHRA 2012/003/001/291/003 FSNMerck Pharmaceutical

(HK) Ltd.

2012/04/03

Finsbury Orthopaedics, Stryker Orthopaedics MITCH TRH acetabular

cups/MITCH TRH modular heads (Finsbury Orthopaedics) when implanted with

uncemented Accolade femoral stems (Stryker Orthopaedics)

MHRA MDA/2012/016 MDA Stryker China Ltd

2012/04/03Agfa Healthcare DX-D 10G, DX-D 10C, DX-D 20G & DX-D 20C - Digital

detectors (connected via cable) for Direct Digital imaging size 35*43cmMHRA 2012/003/013/081/007 FSN

AGFA Hong Kong

Limited

2012/04/03 Codman & Shurtleff MEDSTREAM pump MHRA 2012/002/006/081/002 FSNJohnson & Johnson

Medical (HK)

2012/04/05 Animas Corporation One Touch Ping Insulin Pump Health Canada 72558 Type IIIJohnson & Johnson

Medical (HK)

2012/04/05 Oxoid Company Brilliance Clarity UTI Plates (MP0324) Health Canada 71096 Type IIThermo Fisher


2012/04/05

Beckman Coulter, Inc. A) Unicel DXI 600 Access Immunoassay System -

Instrument Class 2

B) Unicel DXI 600 Access Immunoassay System - Instrument Class 3

C) Unicel DXC 880I Synchron Access Clinical Analyzer

D) Unicell DXI 800 Access Immunoassay - Analyzer-Class 3

E) Unicel DXI 800 Access Immunoassay System - Analyzer - Class II

F) Unicel DXC 660I Synchron Access Clincal Analyzer

G) Unicel DXC 660I Synchron Access Clincal Analyzer

H) Unicel DXC 680I Synchron Access Clincal Analyzer

I ) Unicel DXC 860I Synchron Access Clincal Analyzer

J) Unicel DXI 800 Access Immunoassay Sys-Instrument W/ Spot B Gantry

Class 2

K) Unicel DXI 800 Access Immunoassay Sys-Instrument W/ Spot B Gantry

Health Canada 71627 Type IIBeckman Coulter Hong

Kong Ltd

2012/04/05Baxter Healthcare SA A) Homechoice APD Systems

B) Homechoice Pro APD SystemsHealth Canada 71838 Type III Baxter Healthcare Ltd

2012/04/05 Beckman Coulter Coulter ACT 5 Diff Autoloader Hematology Analyzer (175356) Health Canada 72299 Type IIIBeckman Coulter Hong

Kong Ltd

2012/04/05Carl Zeiss OPMI Lumera 700 Opthalmic Surgical Microscope (305953-9900-

000 and305953-9920-000)Health Canada 72041 Type III

Carl Zeiss Far East Co.,

Ltd

2012/04/05 Stryker Orthopeadics Trident Offset Cup Impactor T6318 [All Lots Numbers] Health Canada 72438 Type I Stryker China Ltd

Major Safety Alerts in April 2012










http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON149600http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON149601










2012/04/05Becton Dickinson and Company BD BBL Fildes Enrichment [Model No.:

211866; Lot No.: 1186346, 1229762]Health Canada 72043 Type II BD

2012/04/05Elekta Business Area Software Sys. ATA Computerized Medical Sys. Inc.

Monaco [Version 3.10.00]Health Canada 72466 Type II Elekta Ltd

2012/04/05

Supersonic Imagine A) SuperSonic Aixplorer Ultrasound System - Main Unit

[SSIP90019]

B) SuperSonic Aixplorer Ultrasound System - Linear Probe [SSIP09002]

C) SuperSonic Aixplorer Ultrasound System - Curved Array Probe [SSIP90030]

D) SuperSonic Aixplorer Ultrasound System - Probe SE12-3 [SSIP90068]

Health Canada 71571 Type IIPrism Technologies

Limited

2012/04/05 Oxoid Limited Oxoid XLS Agar Health Canada 71097 Type IIThermo Fisher


2012/04/05Codman and Shurtleff Inc. Codman I.C.P. Express Monitoring System -

Microsensor KitHealth Canada 72434 Type II

Johnson & Johnson

Medical (HK)

2012/04/05 BrainLAB A) Microscope Integration Kit Zeiss; B) Microscope Integration Leica Health Canada 66443 Type II BrainLAB Ltd

2012/04/10 Healthtronics CRYO-206V and CRYO-206F Procedure Kit FDA Z-1275-2012 Class II N.A.

2012/04/10

Christie Medical Holding 1) VeinViewer (R) by Luminetx, Model Number VV1.0,

Part No: P00399-L; 2) VeinViewer (R) by Luminetx, Model Number VV1.1 GS,

Part No. P00800-L

FDA Z-1280-2012 to Z-1281-2102 Class II N.A.

2012/04/11Edwards Lifesciences Edwards Lifesciences Ascendra2 Transapical Delivery

SystemMHRA 2012/003/015/081/024 FSN

Goodman Medical

Supplies Ltd.

2012/04/11DePuy Orthopeadics DePuy Attune Impaction Handle (Model/Part no.:

254401010)MHRA 2012/004/002/081/025 FSN

Johnson & Johnson

Medical (HK)

2012/04/11DePuy Orthopeadics DePuy Fenestrated Open Alignment Guide (Model/Part

no.: 279726401)MHRA 2012/003/013/081/009 FSN

Johnson & Johnson

Medical (HK)

2012/04/11 Beckman Coulter Access Immunoassay Systems, Vitamin B12 Reagent Kit MHRA 2012/003/028/601/004 FSNBeckman Coulter Hong

Kong Ltd

2012/04/11Baxter Healthcare SA Homechoice Disposable Sets (Model no.: R5C4455,

R5C4478, R5C4479, R5C4479E) and Manifold Sets (Model no.: R5C4427)MHRA 2012/004/004/081/004 FSN Baxter Healthcare Ltd

2012/04/11

Stryker Medical Epic Critical Care beds, Epic Zoom Critical Care beds and

Secure II beds.

Catagloue no.: 2030, 2040, 2031, 3002, 3221Affected lot no: Devices

manufactured between 1st September 2004 and 30th November 2007

MHRA 2012/003/030/291/010 FSN Stryker China Ltd

2012/04/11Siemens Healthcare Diagnostics Ltd lratus® CS Acute Care'" NT• proBNP

TestPak reagent (CPBNPM)MHRA 2012/003/030/601/003 FSN

Siemens Healthcare

Diagnostic Limited

2012/04/11Siemens Healthcare Diagnostics Ltd Dimension Vista® Total Prostate Specific

Antigen (TPSA) Flex® reagent cartridge (K6451)MHRA 2012/004/003/601/006 FSN

Siemens Healthcare

Diagnostic Limited

2012/04/11 Teleflex Hudson RCI BiteGard® oral bite block MHRA 2012/004/003/081/025 FSN N.A.

2012/04/11 Rocket Medical Rocket® Pleuraseal IV(4) Chest Drainage Bottle MHRA 2012/003/028/601/002 FSN N.A.

2012/04/11 Woodway Gmbh Medical PPS series treadmills MHRA 2012/003/027/081/016 FSN N.A.

2012/04/11

Greiner Bio-One A) Item No. 450235 VACUETTE® QUICKSHIELD Complete

PLUS - Safety Tube Holder with 21G x 1" VISIO PLUS Needle;

B) Item No. 450239 VACUETTE® QUICKSHIELD Complete PLUS - Safety

Tube Holder with 21G x 1.5" VISIO PLUS Needle;

MHRA 2012/004/002/081/006 FSN Mekim Ltd

2012/04/11

IDEV Technologies SUPERA VERITAS® Interwoven Self-Expanding Nitinol

Stent Peripheral Vascular System (6F and 7F)MHRA 2012/004/003/081/012 FSN IntegMed Limited

2012/04/11Instrumentation Laboratory HemosIL von Willebrand Factor Activity (Part No.

0020004700)MHRA 2012/004/003/081/021 FSN N.A.

2012/04/11 Ipsogen BCR-ABL Mbcr IS-MMR DX Kit , ref FQPP-10-MMR-DX-CE MHRA 2012/003/028/081/020 FSN N.A.
























2012/04/11Ethicon Endo-Surgery Harmonic® hand piece Harmonic® Blue hand piece and

Blue test tip_HPBLUE, HP054MHRA 2012/004/002/081/020 FSN

Johnson & Johnson

(HK) Ltd.

2012/04/12 Air- or gas-pressurised spray devices for application of sprayable fibrin

sealants used for intra-operative haemostasis.MHRA MDA/2012/019 MDA N.A.

2012/04/14 Oral swabs with a foam head MHRA MDA/2012/020 MDA N.A.

2012/04/17Philips Healthcare Brilliance 6, Brilliance 16, Brilliance 40, Brilliance 64,

Brilliance CT Big Bore, iCT, iCT SP and Ingenuity CTMHRA 2012/004/011/081/029 FSN

Philips Electronics

Hong Kong Ltd

2012/04/17 Philips Healthcare Allura systems. Actuator Monitor Ceiling Suspension (MCS) MHRA 2012/004/011/081/014 FSNPhilips Electronics

Hong Kong Ltd

2012/04/17 Stryker Orthopaedics Restoration Modular Cone Body Trials MHRA 2012/004/010/081/009 FSN Stryker China Ltd

2012/04/17 Gambro Industries Prismaflex/Prisma ST 100/150 Sets [Ref.: MEY-2012-01] MHRA 2012/004/010/081/020 FSNGambro Hong Kong

Ltd.

2012/04/17 GE Medical Systems READY View application software (GE Ref: 80139) MHRA 2012/004/016/291/002 FSNGE Medical Systems

Hong Kong Ltd.

2012/04/17 Ormco Corporation Damon 3MX Bicuspid BracketsSybron Dental

SpecialitiesNA NA

Sybron Dental

Specialties

2012/04/17Abbott Diagnostics Ltd ARCHITECT STAT Troponin-I, List Number 2K41-28,

Lot 74264UN11MHRA 12/004/012/601/005 FSN

Bio-Asia Diagnostics Co

Ltd., Abbott

Laboratories Ltd.

2012/04/17Abbott Point of Care i-STAT® PT/INR cartridge with List Numbers 04J50-01,

04J50-02, 03P89-24 (All lots beginning with R11 and R12)MHRA 2012/003/030/291/006 FSN


Ltd., Abbott

Laboratories Ltd.

2012/04/18Varian Medical Systems 4D Integrated Treatment Console (4DITC) v8.6 or 8.8

in combination with treatment planning systems

Varian Medical

SystemsCP-03063 NA


Pacific Inc.

2012/04/18Varian Medical Systems 4D Integrated Treatment Console (4DITC) versions

8.1.3 to 8.8

Varian Medical

SystemsCP-03556 NA


Pacific Inc.

2012/04/19

Baxa Baxa EVA TPN bags for administering parenteral nutrition solutions. Sold

under three brand names: Exacta Mix EVA Bags, Exacta Mix Dual-Chamber

EVA Halobag, and Baxa Calibration Bags

FDA Z-1420-2012 Class II JASPO Limited

2012/04/19Pharmaceutical Innovations Other-Sonic Generic Ultrasound Transmission Gel

manufactured June through December 2011FDA N.A. NA N.A.

2012/04/19

Siemens Siemens ADVIA Centaur Cortisol Assay, Model/Part no.: 04610138 (1

0321 026)- 250 Test kit 04610049(10309078)- 50 Test kit 04611509 (1

0335503)- 250 REFFDA Z-1390-2012 Class II

Siemens Healthcare

Diagnostic Limited

2012/04/19 Ergolet ApS Ergolet N.A. NA N.A.

2012/04/20

Siemens AG A) Mevatron Linear Accelerators [Model No.: 4504200]

B) Oncor Expression Digital Linear Accelerator [Model No.: 7360717]

C) Artiste MV-Linear Accelerator - Main Unit [Model No.: 8139789]

D) Oncor Impression 3D Plus [Model No.: 5857912]

Health Canada 72876 Type ISiemens Healthcare

Diagnostic Limited

2012/04/20Biomerieux, Inc. Vitek 2 AST-GN27 card [Model No.: 22245; Lot No.:

267215010]Health Canada 72386 Type II bioMerieux China Ltd.

2012/04/20 Elekta Limited MLCi and MLCi2 radiation heads Elekta Ltd 200 01 403 002 NA Elekta Ltd

2012/04/20

Siemens AG A) Mevatron Linear Accelerators; B) Oncor Expression Digital

Linear Accelerator; C) Artiste MV - unité principale d'accélérateur linéaire; D)

Oncor Impression 3D Plus

Health Canada 72450 Type IISiemens Healthcare

Diagnostic Limited

2012/04/20Smiths Medical ASD Inc CADD High Volume Administration Sets (Model/Part

no.: 21-7081v-01 and 21-7381-01)Health Canada 72657 Type II N.A.

2012/04/20

SuperSonic Imagine A) SuperSonic Aixplorer Ultrasound System - Main Unit;

B) SuperSonic Aixplorer Ultrasound System - Linear Probe; C) SuperSonic

Aixplorer Ultrasound System - Curved Array Probe; D) SuperSonic Aixplorer

Ultrasound System - Probe SE12-3


Limited












../AppData/Local/Temp/AppData/Local/Temp/AppData/Local/Temp/AppData/Local/Temp/AppData/Local/Temp/[email protected]/News (Medical Device): http:/www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm299409.htm (MedWatch): http:/www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm300873.htm







2012/04/20 Vascutek Ltd Vascutek Gelweave Vascular Prothesis (Model/Part no.: 732030) Health Canada 72862 Type IIKeymax Technology

(HK) Ltd.

2012/04/20 Medtronic N'Vision Application Card Health Canada 72742 Type IIMedtronic International

Ltd

2012/04/20 Gemoscan Canada Hemocode Blood Collection Kit Health Canada 72297 Type III N.A.

2012/04/20 Roche Diagnostics Online DAT Benzodiazepines II for Cobas Integra Analyzers Health Canada 72332 Type IIIRoche Diagnostics

(Hong Kong) Ltd

2012/04/20GE Medical Systems A) Brivo XR285AMX X-Ray System; B) Optima

XR220AMX X-Ray System; C) Optima XR200AMX X-Ray System Health Canada 72650 Type III

GE Medical Systems

Hong Kong Ltd.

2012/04/20

Ortho-Clinical Diagnostics Inc. A) VITROS 5600 Integrated System (6802413) -

Instrument

B) VITROS 5600 Integrated System (6802413)

C) VITROS 4600 Chemistry System (6802445) - Hardware

Health Canada 72655 Type IIIOrtho Clinical

Diagnostics

2012/04/20

Beckman Coulter Inc. A) Unicel DXC 600i Synchron Access Clinical System

Incubator Belt

B) Access 2 Immunoassay System Incubator Belt

C) Access 2 Immunoassay System Incubator Belt

D) Synchron LXI 725 Clinical System Incubator Belt


Kong Ltd

2012/04/20Beckman Coulter Inc. A) Unicel DXC 800 Pro

B) Unicel DXC 880iHealth Canada 72547 Type III


Kong Ltd

2012/04/20 Siemens AG Syngo Mammocad Health Canada 72852 Type IIISiemens Healthcare

Diagnostic Limited

2012/04/20 2-Channel Vacuum Unit Health Canada 72754 Type III ITO Company Limited

2012/04/20Stryker Medical Impression 1.5 Non-Powered Support Surface_2981-000-997,

2981-000-999Health Canada 72850 Type III Stryker China Ltd

2012/04/23 Smith & Nephew Trauma Pins and Drills (various models)Smith & Nephew

HKR1207 NA Smith & Nephew Ltd.

2012/04/23 Q-MED Macrolane MHRA NA NA Q-MED International Ltd

2012/04/24Cameron Health Cameron Health SQ‐RX® Pulse Generator, Model Number

1010MHRA 2012/004/002/081/002 FSN N.A.

2012/04/24

Galil Medical 17G Cryoablation Needle Holder FPRPR4014 (FSCA identifier:

PAF12-02); [Model no.: FPRPR4014; Affected lot no.: N7729-XXX; N7890-

XXX; N7975-XXX; N8185-XXX; and N9438-XXX]MHRA 2012/004/012/601/006 FSN Galil Medical

2012/04/24 GE Healthcare Rear Pedestal Air Supply Hose on Optima MR450w with GEM MHRA 2012/003/027/081/005 FSNGE Medical Systems

Hong Kong Ltd.

2012/04/24Gen-Probe GTI Diagnostics Inc LIFECODES® Pak12G® [Various Lot

Numbers]MHRA 2012/004/017/081/016 FSN bioMerieux China Ltd.

2012/04/24Siemens AXIOM Artis or Artis Zee operated in conjunction with a wireless foot

switchMHRA 2011/011/021/081/014 FSN

Siemens Healthcare

Diagnostic Limited

2012/04/24 Gen-Probe GTI Diagnostics Lifecodes Quikscreen QS12G MHRA 2012/004/017/081/014 FSN N.A.

2012/04/24Likvor AB Celda tools_CT001-SV-02, CT001-EN-02, CT001-DA-02, CT001-FI-

02MHRA 2012/004/017/081/001 FSN N.A.

2012/04/24M.A. Arain & Brothers (Pvt) Ltd Laryngoscope battery handles_670160-000030

and 670160-000040_041511MHRA 2012/004/016/081/021 FSN N.A.

2012/04/24Pennine Healthcare Procedure packs containing Sarns™ Soft-Flow™ aortic

cannula with angled tip manufactured by TerumoMHRA 2012/003/013/081/005 FSN N.A.

2012/04/24Philips Healthcare DigitalDiagnost with software version 2.x and the image

stitching optionMHRA 2012/004/018/081/017 FSN

Philips Electronics

Hong Kong Ltd

2012/04/24Beckman Coulter UniCel® DxH™ 800 Coulter® Cellular Analysis System, PN

629029MHRA 2012/004/013/601/002 FSN


Kong Ltd

2012/04/24Biomet 3i Dental Full Osseotite® Tapered Certain® Implant, item no IFNT611;

lot no 2011110798MHRA 2012/004/013/081/012 FSN Ositek (HK), Inc. Ltd














http://www.mhra.gov.uk/NewsCentre/CON149797













2012/04/25 Bayer HealthCare MEDRAD® CONTINUUM PUMP AND TUBING SET

Prism

Technologies

Limited

NA NAPrism Technologies

Limited

2012/04/27Philips Medical Systems Brilliance Workspace IntelliSpace Portal, M/N 728269

(System Code: 881001, Software release 4.0.0)FDA Z-1337-2012 Class II

Philips Electronics

Hong Kong Ltd

2012/04/27

MOOG Non-DEHP Microbore Administration Sets, Epidural Administration Sets

(Model no: 340-4114, 340-4115, 340-4126, 340-4127, 340-4128, 340-4128v,

340-4130, 340-4130v, 340-413, 340-4137, 340-4144, 340-4162, 340-4164, 340-

4165, 340-4166, 340-4168, 340-4169 and 340-4123)

FDA Z-1401-2012 to Z-1419-2012 Class IIMoog Controls Hong

Kong Ltd.

2012/04/27 BD Diagnostics BD PrepMate Syringing Pipette BD NA NA BD

2012/04/30BD Diagnostics BD Phoenix System Software, Cat. No. 448035/448046, and

BD Phoenix Update Disks (PUD), Cat. No. 441107/448047BD NA NA BD



Date of Issue

(YYYY/MM/D

D)



Alert Type by

SourceLocal Agent

2012/03/02

Ascension Orthopedics, Inc Ascension Orthopedics First Choice Partial Ulnar

Head System ("DRUJ System") (Model/Part no.: DRUJ-610-1445-WW, DRUJ-

610-1455-WW, DRUJ-610-1465-WW, DRUJ-610-1645-WW, DRUJ-610-1655-

WW, DRUJ-610-1665-WW, DRUJ-610-1745-WW, DRUJ-610-1755-WW,

DRUJ-610-1765-WW, DRUJ-610-1945-WW, DRUJ-610-1955-WW, and DRUJ-

610-1965-WW)


2012/03/02Alere San Diego Strep A Rapid Test Cassette (K031784), IST-502 Cassettes;

Strep A Twist Rapid Test Cassette (K023766), IST-502T Twist CassettesFDA Z-1074-2012 to Z-1075-2012 Class II N.A.

2012/03/02

Varian Medical Systems Varian 52-leaf Standard MLC multileaf collimator; 52-

leaf Millennium MLC multileaf collimator (Model/Part no.: H52, H54, H56, HHM) FDA Z-1090-2012 Class IIVarian Medical Systems

Pacific Inc.

2012/03/02

Accuray CyberKnife Robotic Radiosurgery System with 4D Planning procedure

option of MultiPlan Treatment Planning System (Model/Part no.: versions 3.0,

3.1, 3.5.1, 3.5.2 and 3.5.3)

FDA Z-1098-2012 Class II Accuray Asia Ltd

2012/03/06 Philips Medical Systems HeartStart FR3 Carry Case MHRA2012/002/029/291/010

FSNPhilips Electronics

Hong Kong Ltd

2012/03/06Philips Medical Systems HeartStart FR3 Automated External Defibrillators

Mandatory Software UpdateMHRA

2012/002/028/291/006FSN

Philips Electronics

Hong Kong Ltd

2012/03/06Thermo Fisher Scientific Oxoid Antimicrobial Susceptibility Testing Disc, SXT25

(Sulphamethoxazole\Trimethoprim), CT0052B, Lot 1114277MHRA 2012/002/027/601/004 FSN

Thermo Fisher

Scientific (HK)

2012/03/06 Aesculap AG Columbus Rev F Tibia Offset Cemented MHRA 2012/002/029/081/018 FSN N.A.

2012/03/06Beckman Coulter UK Ltd Coulter TruColor Giemsa Stain, Coulter TruColor May-

Grunwald StainMHRA 2012/002/024/601/003 FSN


Kong Ltd

2012/03/06 Bio-Rad Medical Diagnostics GnbH Biotestcell- I11, I11E MHRA 2012/002/027/291/013 FSN N.A.

2012/03/06 GE Healthcare GEHC Infinia Nuclear Medicine systems MHRA 2012/003/002/291/007 FSNGE Medical Systems

Hong Kong Ltd.

2012/03/06 Fujifilm Medical Systems Fujifilm FDR-1000AWS, FDR-2000AWS MHRA 2012/002/016/291/012 FSN N.A.

2012/03/06Interlerad Medical Systems INTELEPACS Versions 3.2.1 and up [reference:

EW241135]MHRA 2012/002/028/291/013 FSN

Interlerad Medical

Systems

2012/03/06Roche Diagnostics Ltd Cobas c-pack MULTI [cobas c311 cobas c 501 cobas c

502]MHRA

2011/011/018/401/009FSN

Roche Diagnostics

(Hong Kong) Ltd

2012/03/06Sybron Dental Specialities AlgiNot FS Volume (Model/Part no.: 34683, 34682;

Affected lot number: 1‐1017)MHRA 2012/002/027/081/019 FSN N.A.

2012/03/06 Siemens Healthcare Diagnostics Enzygnost® HBsAg 6.0 MHRA 2012/002/022/601/006 FSNSiemens Healthcare

Diagnostic Limited

2012/03/06 Thermo Fisher Scientific Oxoid Ready Poured Plate, CLED Agar MHRA 2012/002/028/601/003 FSNThermo Fisher

Scientific (HK)

2012/03/06Medtronic, Inc EnTrust(r) D153DRG, D153VRC, D153ATG, D154VRC,

D154DRG and D154ATG and Escudo D144DRG, D144VRCMedtronic N.A. NA


Ltd

2012/03/07 Standard Diagnostics, Inc SD Bioline HIV 1/2 v3.0 WHO N.A.Information

UpdateBio-Asia

2012/03/07 Varian Medical Systems 4D Integrated Treatment Console and TrueBeamVarian Medical


2012/03/07Varian Medical Systems Eclipse Treatment Planning System Eclipse Treatment

Planning System, 7.3, 8.0, 8.1, 8.2, 8.6, 8.9, 10.0

Varian Medical


Major Safety Alerts in March 2012




















http://www.who.int/diagnostics_laboratory/procurement/120106_final_update_info_sd_bioline_hiv_rtd.pdf

2012/03/08

Canon Inc. A) CXDI-55C Digital Radiography Imager

B) CDXI-55G Digital Radiography X-Ray Imager

C) Digital Radiography CXDI Wireless

Health Canada 71624 Type III Cannon Hong Kong

2012/03/08Siemens Healthcare Diagnostics, Inc Dimension Vista System-Magnesium

AssayHealth Canada 71628 Type III

Siemens Healthcare

Diagnostic Limited

2012/03/08 Medtronic, Inc ENT Spear Tip Blades, ENT Upcutting Blades Health Canada 71623 Type IIIMedtronic International

Ltd

2012/03/08Supersonic Imagine Aixplorer Ultrasound System (SSIP90019 and SSIP09002

(SL15-4), version 4.X)Health Canada 71652 Type III

Prism Technologies

Limited

2012/03/08Cinncinnati Sub-Zero Products Steri-Probe Rectal / Esophageal Temperature

Probe (Model no..: 491B)Health Canada 68314 Type II N.A.

2012/03/08 Siemens Healthcare Diagnostics Factor VIII Chromogenic Assay Health Canada 71092 Type IIISiemens Healthcare

Diagnostic Limited

2012/03/08 GE Healthcare Innova 4100IQ Health Canada 71317 Type IIIGE Medical Systems

Hong Kong Ltd.

2012/03/08 3M Health care Optreoz Sterilizer (Model no.: 125-Z) Health Canada 71321 Type III 3M Hong Kong Ltd

2012/03/08 Roche Diagnostics Ltd. Cobas Ampliprep Sample Tubes Health Canada 71298 Type IIIRoche Diagnostics

(Hong Kong) Ltd

2012/03/08 Thermor Ltd. Bios Rollator [Model: 56001; Lot No.: 1110-13870] Health Canada 71445 Type I Thermor Ltd.

2012/03/08

Bomimed Inc A) Air-Flex Anesthesia Mask - Neonatal (OL-081105-00); B) Air-

Flex Anesthesia Mask - Infant (OL-081110-00); C) Air-Flex Anesthesia Mask -

Child (OL-081120-00); D) Air-Flex Anesthesia Mask - Adult (OL-081130-00, OL-

081140-00, OL-081150-00); [Lot No: 072111]

Health Canada 71414 Type II Bomimed Inc

2012/03/08

Varian Medical Systems EMC issue : A) Eclipse Ocular Proton Planning V1.1

(TPA001075000) ; B) Eclipse Smart Segmentation (TPA001094000); C)

Rapidarc, Also known as Dose Dynamic Arc / Volumet (UP9001); D) Eclipse

TPS V8.8 (100042024);


Pacific Inc.

2012/03/08

Varian Medical Systems MLC issue : A) Eclipse Ocular Proton Planning V1.1

(TPA001075000) ; B) Eclipse Smart Segmentation (TPA001094000); C)

Rapidarc, Also known as Dose Dynamic Arc / Volumet (UP9001); D) Eclipse

TPS V8.8 (100042024);


Pacific Inc.

2012/03/08Cinncinnati Sub-Zero Products 115 Volt Warmair 135 Convective Warming Unit

06186, 86186Health Canada 71305 Type II

Cinncinnati Sub-Zero

Products

2012/03/08

Varian Medical Systems A) Varisource IX Afterloader

B) Varisource IX(T) (Transportable) Afterloader

C) Varisource Series 200 HDR Afterloader Health Canada 71514 Type II


Pacific Inc.

2012/03/08

Radiometer Medical APS BL80 Flex (with Flex or Basic software)

Model/Part no.: 393-839, 903-227

Affected lot number: 304157, 304160, 304162 through to 305409,

Signal Data Board >May 2011

Health Canada 71558 Type IIRadiometer China

(RCHN)

2012/03/08

Diasorin Inc. ETI-VCA-IGG

Model/Part no.: P001606A

Affected lot number: 3010580B, 3010580B/1Health Canada 71681 Type II N.A.

2012/03/08

Supersonic Imagine Aixplorer Ultrasound System

Model/Part no.: SSIP90019, SSIP09002 (SL15-4), SSIP90055 (SLV16-5)

SSIP90030 (SC6-1), SSIP90068


Limited

http://hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_jan-mar_2012-eng.php


















2012/03/08 Coloplast A/S Self-Cath Catheter Health Canada 71495 Type IIColoplast (Hong Kong)

Ltd

2012/03/08ARES Trading S.A. (An affiliate of Merck KGAA Darmstadt, Germany)

RebiSmart Auto-InjectorHealth Canada 71481 Type II

Merck Pharmaceutical

(HK) Ltd.

2012/03/08 Smith & Nephew Inc., Endoscopy Division Biosure HA Interference Screw Health Canada 71323 Type II Smith & Nephew Ltd.

2012/03/08 Nobel Biocare AB Nobelactive RP 5x15mm Health Canada 71368 Type II Nobel Biocare Asia Ltd.

2012/03/08 Smith & Nephew Inc Universal Femoral Head, 32mm+12 Health Canada 71444 Type II Smith & Nephew Ltd.

2012/03/08 Boston Scientific SoloistTM Single Needle Electrode Boston Scientific 90748268-FA NA Boston Scientific

2012/03/09B. Braun Medical B. Braun Infusomat Space Pump - US Version Infusion pump

(Model no.: 8713050U)FDA Z-1015-2012 Class I

B. Braun Medical Hong

Kong

2012/03/09Philips Medical Systems Philips Intellispace Portal, Release 4.0.0.

Mandatory Software UpdateFDA Z-1125-2012 Class II

Philips Electronics

Hong Kong Ltd

2012/03/09 Zeiss, Carl Inc. Carl Zeiss Microimaging Laser-TIRF and DirectFRAP FDA Z-1129-2012 Class IICarl Zeiss Far East Co.,

Ltd

2012/03/09 Terumo Soft-Flow Aortic Cannula with angled tip Terumo AA-2011-027-R NATerumo China (Hong

Kong) Ltd.

2012/03/09Terumo CDI™ Blood Parameter Monitoring System: System Battery

MaintenanceTerumo AA-2011-019-C NA

Terumo China (Hong

Kong) Ltd.

2012/03/09Varian Medical Systems Varian brand ARIA Radiation Oncology, ARIA versions

10.0.39 and below, Reference/FSCA Identifier: CP-06070,FDA Z-0713-2012 Class II


Pacific Inc.

2012/03/09AngioDynamics Inc Angiodynamics DuraMax Chronic Hemodialysis Catheter

Set (with Cuff from Tip) various modelsFDA Z-0718-2012 to Z-0733-2012 Class II AngioDynamics Inc

2012/03/13Medtronic, Inc ATLANTIS™ / PREMIER® / VERTEX ® 876-460, 6860460 and

6905712MHRA 2012/003/002/081/021 FSN


Ltd

2012/03/13 P3 Medical Laryngeal airway masks (silicone, reinforced), lot number 11C01 MHRA 2011/009/028/401/004 FSN N.A.

2012/03/13 Siemens AG Siemens syngo.plaza, version VA20C_HF01 MHRA 2012/003/005/081/005 FSNSiemens Healthcare

Diagnostic Limited

2012/03/13Siemens AG Siemens syngo.plaza with USB dongle and archive license,

version VA20B_HF04MHRA 2012/003/005/081/004 FSN

Siemens Healthcare

Diagnostic Limited

2012/03/13Thermo Fisher Scientific Oxoid Ready Poured Plate BrillianceTM MRSA 2 Agar

PO1210A, Lot Number 1203789.MHRA 2012/003008/601/001 FSN

Thermo Fisher

Scientific (HK)

2012/03/13 ArjoHuntleigh Auto Logic Pump Units and PCBAs MHRA 2012/001/017/081/007 FSNArjo Huntleigh (Hong

Kong) Ltd.

2012/03/13 BioLytical Laboratories INSTI HIV-1/HIV-2 Antibody Test Kits MHRA 2012/001/020/401/011 FSN N.A.

2012/03/13 Biomet T.E.S.S. Glenoid Anatomic Polyethylene Inlay MHRA 2012/003/007/291/004 FSN N.A.

2012/03/13 Critical Diagnostics Presage® ST2 Assay kits MHRA 2012/003/007/081/011 FSN Critical Diagnostics

2012/03/13

DiaSorin Inc. ETI-VCA-G

Model/Part no.: P001606

Affected lot no: 3010580A, 3010580A/1, 3010580A/2MHRA 2012/002/020/081/025 FSN DiaSorin Inc.

2012/03/13Medex/ Guerbet Laboratories IV administration sets [KSB/I/S] & [KSB/PI/S];

Compatible with the SBI CT injector (SBI 5002-CT) in two-bad mode MHRA 2012/001/024/081/020 FSN Hind Wing Co. Ltd

2012/03/14 Acclarent Inc. Acclarent Inspira AIR Balloon Dilation System, size 18x40mm FDA NA Class I N.A.

2012/03/16Abbott Molecular Inc HCV Genotype II m2000 System ROW Combined

Application CD-ROM Version 3.0

Abbott Molecular

IncN.A. NA Abbott Laboratories Ltd.

2012/03/16Siemens AG ARTISTE, ONCOR and PRIMUS Linear Accelerators with RT

Therapist Workspace, version 4.1FDA Z-1092-2012 Class II

Siemens Healthcare

Diagnostic Limited

2012/03/16GE Healthcare GE eXplore Locus Micro CT cabinet x-ray system Model: RS9-

80; Part no.: 5134163FDA Z-0833-2012 Class II

GE Medical Systems

Hong Kong Ltd.

2012/03/16Microsoft Corporation Health Solutions Group Microsoft Amalga - previously

known as Microsoft Amalga Unified Intelligence System (UIS) 2009FDA Z-1082-2012 Class II N.A.


























2012/03/16Siemens AG Siemens mMLC (Moduleaf) safety bar and trolley label

Model/ Part no.: 110V/60Hz 7334043 & 220V/60Hz 7334050FDA Z-1184-2012 Class II

Siemens Healthcare

Diagnostic Limited

2012/03/20 Varian Medical Systems All FastPlan versions (Possible error in CT)Varian Medical

SystemsCP-07299 NA


Pacific Inc.

2012/03/20Varian Medical Systems Eclipse™ treatment planning system, Versions 7.3,

8.0, 8.1, 8.2, 8.6, 8.9 and 10.0

Varian Medical

SystemsCP-07504 NA


Pacific Inc.

2012/03/20Waldemar Link GmbH Trial Neck XXL, length 65mm – Instrument for the MP

Reconstruction Prosthesis (Model/Part no.: 131-394/26; 131-394/35)MHRA 2012/003/008/081/001 FSN N.A.

2012/03/20 Philips Healthcare MultiDiagnost Eleva II, product code 708032, PBL 4.1.x MHRA 2012/003/012/291/006 FSNPhilips Electronics

Hong Kong Ltd

2012/03/20Smith & Nephew Inc TRIGEN META Semi-Extended Drill Guides, Product code

71654524MHRA 2012/003/009/081/004 FSN Smith & Nephew Ltd.

2012/03/20

Thermo Fisher Scientific Oxid Antimicrobial Susceptiability Testing Disc CN30

GENTAMICNMHRA 2012/003/009/601/009 FSN

Thermo Fisher

Scientific (HK)

2012/03/20Abbott Diagnostics Ltd i-STAT cTnI cartridge (List no.: 06F15-03, 06F15-04,

03P90-25, 600-9009-25)MHRA 2012/003/013/081/004 FSN


Ltd., Abbott

Laboratories Ltd.

2012/03/20BrainLAB All Brainlab BrainSCAN and iPlan RT treatment planning software

versionsMHRA 2012/003/013/291/002 FSN BrainLAB Ltd

2012/03/20 Immucor Inc. Galileo Echo Blood Bank Analyzer Cat No.: 0087000 MHRA 2012/003/012/291/001 FSN Uninet Technology LTD

2012/03/20 Medtronic, Inc SynchroMed® II Pump [Medtronic reference : FA535] MHRA 2012/003/012/081/006 FSNMedtronic International

Ltd

2012/03/20

One Lambda Inc. Micro SSP™ Allele Specific HLA Class I DNA Typing Tray –

AB [Model no.: SSP1-AB; Lot Number: 003, batch 007] MHRA 2012/003/009/081/027 FSNMDSS GmbH

(Germany)

2012/03/20

One Lambda Inc. Micro SSP™ Allele Specific HLA Class I DNA Typing Tray -

B*35 [Model no.: SSPR1-35; Lot Number: 002, batch 004] MHRA 2012/003/012/291/002 FSNMDSS GmbH

(Germany)

2012/03/21 Beckman Coulter Inc. Prealbumin (Model no. OSR6175) Health Canada 71442 Type IIIBeckman Coulter Hong

Kong Ltd

2012/03/21 Siemens AG Axiom Luminos DRF System-Main Unit Health Canada 71452 Type IIISiemens Healthcare

Diagnostic Limited

2012/03/21

GE Medical Systems Information Technologies, Inc. CIC Pro Clinical

Information Center (Model/Part no.: CIC-XXXX-XXXXX-XXXXX*) Health Canada 71826 Type IIIGE Medical Systems

Hong Kong Ltd.

2012/03/21

Supersonic Imagine Aixplorer System - Linear Probe (SL-15-4) (Model/Part no.:

SSIP09002 (SL15-4)) Health Canada 71677 Type IIIPrism Technologies

Limited

2012/03/21

CardianBCT Inc. A) Cobe Trima Blood Collection System

B) Trima Accel LRS Platelet, Plasma, RBC Set

C) Trima Accel Enhanced Platelet, Plasma, RBC Set

D) Trima Accel LRS Platelet, Plasma, RBC, and TLR Filter Set

Health Canada 71626 Type IICaridianBCT (Hong

Kong) Ltd

2012/03/21

Liebel-Flarsheim Company A) Y Tubing Optistar/Coiled Extension Tubing

B) Optistar Mr. Injection System

C) Optistar Le Contrast Delivery System

Health Canada 71635 Type II

Covidien Hong Kong

Limited

2012/03/21 Hologic SecurView DX Diagnostic Workstation, Software Version 7.3.0 Health Canada 71960 Type IIPrism Technologies

Limited

2012/03/21 Lifescan Onetouch Verio IQ Blood Glucose Meters 011-838 Health Canada 71989 Type IIJohnson & Johnson

Medical (HK)












http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_jan-mar_2012-eng.php








2012/03/21Ortho-Clinical Diagnostics Inc. VITROS Chemistry Products ALT Slides

(1655281)Health Canada 71454 Type III

Ortho Clinical

Diagnostics

2012/03/21 Kerr Corporation Tytin FC Fast Set Capsules Health Canada 71184 Type III N.A.

2012/03/21

Philips Medical Systems (Cleveland) Inc A) Brilliance 40-64 Slice CT System-

Workspace Portal; B) Brilliance 6/1016 Slice CT Sytem - Extended Brilliance

Workspace Portal; C) Brilliance 40-64 Slice CT System - Extended Brilliance

Workspace Portal; D) Brilliance ICT System - Extended Brilliance Workspace

Portal; E) Intellispace Portal DX

Health Canada 71630 Type IIPhilips Electronic Hong

Kong Ltd

2012/03/21

Waverley Glen Systems - Division of Prism Medical Ltd. A) Waverley Glen

Griffin Lifts equipped with the "Griffin Reacher Arm Carabiner"; B) TP Lifts

equipped with the "Griffin Reacher Arm Carabiner"


2012/03/21 DMX-Works Inc Digital Motion X-Ray System D100S, D100M Health Canada 71852 Type II N.A.

2012/03/21 Smithys Medical ASD, Inc. Medfusion 4000 Syringe Pump Health Canada 71618 Type II N.A.

2012/03/21Roche Diagnostics Ltd. PSM Software version 2.02.02C [Model #:4944607001;

Lot: version 2.02.02C]Health Canada 72199 Type I

Roche Diagnostics

(Hong Kong) Ltd

2012/03/21

Cardinal Health A) Cardiac Catheterization Pack [Model: SAN30LHTGB]; B)

Custom Sterile Radical Prostate Pack [Model: SOT30RPVRF] Health Canada 71614 Type II Cardinal Health

2012/03/21 Metrex Research Pinnacle Cure Sleeves [Model: 4511; Lot: 20008270110] Health Canada 68638 Type IISybron Dental

Specialties

2012/03/21Capintec Inc. Radioisotope Dose Calibrator CRC 25R [Model: CRC 25R; Lot:

270333]Health Canada 71594 Type II Capintec Inc.

2012/03/21 Philips Medical Systems Intellispace Portal DX Health Canada 71839 Type IIIPhilips Electronics

Hong Kong Ltd

2012/03/21Ormco Corporation Medium Absorbent Points

Model/Part no.: 16218, Affected lot number: 7200905Health Canada 72009 Type III

Citicon (Hong Kong)

Ltd., D & R Dental

2012/03/21Biomerieux BV NucliSENS Magnetic Silica ref 280133

Health Canada 71179 Type III bioMerieux China Ltd.

2012/03/21

Nobel Biocare AB Nobelreplace CC RP 5.0X8MM

Model: 36710

Affected lot number: 462574

Health Canada 72044 Type III Nobel Biocare Asia Ltd.

2012/03/2192000) lot no.255830, 262143, 262838, 259628, 259954

B) Triage Drugs of Abuse Plus TCA 25 Test Kit, PN 92008 Model (92008 )lot

no. 259403NA


2012/03/21

Philips Healthcare Philips HeartStart MRx monitor/defibrillator, Model/Part no.:

M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M4, M3536M5,

M3536M6

Philips

HealthcareCIL 86100108 N.A.


Kong Ltd

2012/03/21 Terumo Terumo Advanced Perfusion System 1:6‖ Roller Pump Occlusion Terumo AA-2011-015-C NATerumo China (Hong

Kong) Ltd.

2012/03/21 Boston Scientific Imager II Catheter (Urology) Boston Scientific 90752558-FA NA Boston Scientific

2012/03/21 Boston Scientific Imager II Angiographic Catheter (Peripheral Intervention) Boston Scientific 90752558 Ver AA NA Boston Scientific

2012/03/23 Philips Healthcare HeartStart XL+ (861290) Defibrillator/MonitorPhilips

HealthcareCIL 86100109 NA


Kong Ltd

2012/03/26

Clarity Medical Systems Inc., Pleasanton, CA Retcam3 & Retcam Shuttle with

version 6.0 software.

A)Model number RC3, part number 21-100500

B)Model number RCS, part number 20-000300


2012/03/27DePuy Mitek Anchor Bone Implanted Ligament [Affected lot number: 3549274,

3549296, 3549732, 3549621,3549273, 3547740]MHRA 2012/003/022/081/022 FSN

Johnson & Johnson

(Hong Kong) Ltd.



../AppData/Local/Temp/AppData/Local/Temp/AppData/Local/Temp/AppData/Local/Temp/AppData/Local/Temp/AppData/Local/Temp/AppData/Local/Temp/Rar$DI77.944/:http:/www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_jan-mar_2012-eng.php














http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON146746

2012/03/27

OptiMed GmbH AltaFlow Measuring Catheter pigtail 5F(1.67mm) x 110cm

[Model no.:1080-4100; Lot number: 6000073905] MHRA 2012/003/019/081/012 FSN OptiMed GmbH

2012/03/27

QRS Diagnostic QRS Diagnostic Universal ECG 12 Lead IEC ECG Devices

[Model/Part no.: Z-7000-0400] MHRA 2012/002/014/601/003 FSN QRS Diagnostic

2012/03/27

Ranier Technology Limited Cadisc™ -L Distractor [Model/Part no.:RTI-010-

0305 (P000946); Lot number: S1008003, S1102189] MHRA 2012/003/016/291/006 FSNRanier Technology

Limited

2012/03/27 Siemens Healthcare Diagnostics, Inc MAGNETOM ESSENZA MHRA 2012/003/015/291/002 FSNSiemens Healthcare

Diagnostic Limited

2012/03/27The Spectranetics Corporation 12 Fr SLS II Laser Sheath [Model/Part no.: 500-

001]MHRA 2012/003/015/291/016 FSN

The Spectranetics

Corporation

2012/03/27

Venner Medical Venner™ A.P. Advance ™ Video Laryngoscope Difficult Airway

Blade (DAB) [Model/Part no.: 700170;Lot number: FM10080006, FM10110007,

FM11010001]MHRA 2011/007/011/601/004 FSN Venner Medical

2012/03/27Waters Corporation ACQUITY Sample Organizer [Model/Part no.: 186015020]

MHRA 2012/003/020/081/004 FSN Waters Corporation

2012/03/27Biomerieux BV BacT/ALERT® Blood Collection Adapter Cap

A) 279012, B) 210361MHRA 2012/003/015/291/001 FSN bioMerieux China Ltd.

2012/03/27 Diagmed Healthcare Ltd Indigo Carmin Sterile MHRA 2011/009/019/081/013 FSN N.A.

2012/03/27

Ethicon Endo-Surgery ECHELON™ 60 ENDOPATH® STAPLER Endoscopic

Linear Cutter (Straight)

A) ECHELON™ 60 ENDOPATH® STAPLER Endoscopic Linear Cutter

(Straight, 340mm)

B) ECHELON™ 60 ENDOPATH® STAPLER Compact Endoscopic Linear

Cutter (Straight, 280mm)

C) ECHELON™ 60 ENDOPATH® STAPLER Long EndoscopiC Linear Cutter

(Straight, 440mm)

MHRA 2012/003/019/081/014 FSNJohnson & Johnson

(Hong Kong) Ltd.

2012/03/27 Abbott Aliquoter Module connected to FlexLab 3.6 MHRA 2012/003/022/081/021 FSN Abbott Laboratories Ltd.

2012/03/27

Meditech Systems Ltd 22835XMMS Bacterial / viral HME filter with X-tendable

catheter mount + elbow MHRA 2012/002/007/601/003 FSN N.A.

2012/03/30 Roche Diagnostics Ltd. Elecsys 2010 Analyzer Software version 06-07 FDA Z-1218-2012 Class IIRoche Diagnostics

(Hong Kong) Ltd

2012/03/30

Smith & Nephew RENASYS Port Foam Dressing Kit Port [Model/Part no.:

66800694] FDA Z-0875-2012 Class II Smith & Nephew Ltd.

2012/03/30Kerr Corporation 1) Artiste Nano-Hybrid Affected Product; 2) Flow Tec Nano-

Hybrid Flowable Affected ProductFDA Z-0989-2012, Z-0990-2012 Class II N.A.

2012/03/30Philips Healthcare 1) Philips MultiDiagnost Eleva II Software Version R4.1.x

Model: 708032; 2) Philips MultiDiagnost Eleva FD, Software R5.1.x Model: FDA Z-1196-2012, Z-1197-2012 Class II

Philips Electronics

Hong Kong Ltd

2012/03/30Smith & Nephew 560P High Definition Camera Control Unit; [Product

code:72201919; Batch No. BBS1203 &BBS1450]Smith & Nephew N.A. NA Smith & Nephew Ltd.

















Date of Issue

(YYYY/MM/D

D)



Alert Type by

SourceLocal Agent

2012/02/01 Polyurethane-coated breast implants MHRA N.A. News N.A.

2012/02/01

Philips Healthcare TumorLOC in Brilliance CT Big Bore, Extended Brilliance

Workspace (EBW), GEMINI GXL 16, GEMINI TF 16, GEMINI TF 64, GEMINI

TF Big Bore

Philips

HealthcareCLE11-003 NA

Philips Electronics

Hong Kong Ltd

2012/02/01 Abbott Molecular Inc Abbott Molecular Bar Code Scanner User's GuideAbbott Molecular

IncN.A. NA N.A.

2012/02/01Cordis (a Johnson & Johnson company) Cordis S.M.A.R.T. ® CONTROL®

Nitinol Stent System

Johnson &

Johnson (Hong

Kong) Ltd

N.A. NAJohnson & Johnson

(Hong Kong) Ltd

2012/02/02 Maquet Critical Care AB Servo-I Ventilator System (64 87 800 E407E) Health Canada 70581 Type IIMAQUET Hong Kong

Limited

2012/02/02GE Healthcare Discovery NM/CT 670 (Mode no.: 5376204-XX / lot 21048 and

20158)Health Canada 70427 Type II

GE Medical Systems

Hong Kong Ltd.

2012/02/02 Toshiba Medical Systems Corporation Radrex Radiographic System - Main Unit Health Canada 70422 Type IIISanko Medical Systems

(HK) LTD

2012/02/02 Oxoid Limited Amoxicillin + Clavulanic Acid 30ug disc Health Canada 70182 Type IIThermo Fisher


2012/02/02

Siemens AG Axiom Aristos FX Plus ( X-Ray Tubes) [Model/Part no.: 10093864;

Serial Number:1324] Health Canada 70421 Type IISiemens Healthcare

Diagnostic Limited

2012/02/02 Kimberly-Clark MIC Gastro-Enteric Feeding Tube, 22F Health Canada 70252 Type IIKimberly-Clark (Hong

Kong) Limited

2012/02/02

Greiner Bio-One Vacuette 4mL EDTA K2 Tubes [Model/Part no.: 454209; Lot

number: B051111] Health Canada 66418 Type II Mekim Ltd

2012/02/02

Tripath Imaging, Inc. (1)BD FocalPoint Slide Profiler, module: 799-00256-XX,

lot: 00178R, 00382, 00383, 00386, 0442-0445, 0451, 0453 & (2)BD FocalPoint

Slide Profiler (refurbished), module: 799-00256-XX, lot: 0037R

Health Canada 70423 Type IIIBecton Dickinson Asia

Limited (BD)

2012/02/02Roche Diagnostics GMBH Hemoglobin A1C (HBA1C), module: 5336163190,

lot: All lotsHealth Canada 70703 Type III

Roche Diagnostics

(Hong Kong) Ltd

2012/02/06 Novomedicus 1) The Artificial Bur Patch; 2) The Artificial Bur HypoPack FDA Z-0919-2012 to Z-0920-2012 Class II N.A.

2012/02/06

Gulf Medical Fiberoptics, Inc. Surgical Headlight Model Numbers: GMF-H001,

GMF-H100, GMF-H101, GMF-H102, GMF-H103, GMF-H104, GMF-H105, and

GMF-H106


2012/02/06 GE Ultrasound Korea GE LOGIQ P6 Ultrasound System FDA Z-0834-2012 Class IIGE Medical Systems

Hong Kong Ltd.

2012/02/06Chien Ti Enterprise Co., Ltd Leo 3-Wheel Scooter and Leo Scooter, Model #

LEO-4BFDA Z-0774-2012 Class II

Chien Ti Enterprise Co.,

Ltd

2012/02/07 Hill-Rom NP150 viscoelastic mattress MHRA 2012/001/030/081/012 FSN N.A.

2012/02/07

Philips Healthcare MultiDiagnost Eleva FD, Product code: 708037, Software

release: PBL 6.1.1 MHRA 2012/002/001/181/002 FSNPhilips Electronics

Hong Kong Ltd

2012/02/07Philips Healthcare MultiDiagnost Eleva II R6.1.1, product code 708036

MHRA 2012/002/001/181/001 FSNPhilips Electronics

Hong Kong Ltd

Major Safety Alerts in February 2012



http://www.mhra.gov.uk/NewsCentre/CON140879

















2012/02/07Sorin Group Deutschland GmbH Sorin Group perfusion system – Pump Speed

ControlMHRA 2012/001/030/081/002 FSN IntegMed Limited

2012/02/07Wescott Medical Limited Sae-Flo MD Extension Set with Y-Connector,

Catalogue No.:WEPCA200AY, Lot: 2011-1510MHRA 2012/001/020/601/001 FSN Wescott Medical Ltd

2012/02/07Beckman Coulter UK Ltd IMMAGE® Immunochemistry Systems Rheumatoid

Factor (RF) ReagentMHRA 2012/001/031/601/008 FSN


Kong Ltd

2012/02/07Biomet Merck France SARL Vanguard ROCC-Reamer, Vanguard ROCC-

Finned Punch TowerMHRA 2012/001/027/081/005 FSN N.A.

2012/02/07 Advanced Sterilization Products STERRAD® 200 System MHRA 2012/001/031/081/002 FSNJohnson & Johnson

(Hong Kong) Ltd.

2012/02/08 North American Rescue, LLC FDA N.A.Firm Press

ReleaseN.A.

2012/02/09Sorin Group Deutschland GmbH Revolution Centrifugal Blood Pump with PC

CoatingHealth Canada 70430 Type III IntegMed Limited

2012/02/09 Roche Diagnostics GMBH Urisys 1800 and Process System Manager Health Canada 70706 Type IIIRoche Diagnostics

(Hong Kong) Ltd

2012/02/09 Keymed Olympus Endoscopic Flushing Pump System - Irrigation Tube Health Canada 70184 Type IIIOlympus Hong Kong

and China Ltd

2012/02/09 Toshiba Medical Systems Corporation Ultimax-I X-Ray Systems Health Canada 70195 Type IIISanko Medical Systems

(HK) LTD

2012/02/09

Airway Surgical Appliances Ltd. A) 20-30 mm/hg below Knee ;

B) 20-30 mm/hg above Knee;

C) 20-30 mm/hg Pantyhose;

D) 30-40 mm/hg Knee High;

E) 30-40 mm/hg above Knee


2012/02/09 Beckman Coulter Inc. RF Latex Calibrator Health Canada 70580 Type IIIBeckman Coulter Hong

Kong Ltd

2012/02/09Health Canada Non-Invasive Ventilation Devices (CPAP, VPAP/BiPAP) - Risk

of Being Used as Life-supporting Ventilators Health Canada NA

Advisory to

Health

Professionals

N.A.

2012/02/09 Zoll Medical Corporation Pedi-Padz Reduced Energy Electrode Health Canada 70567 Type IISuburfarm Investment

& Trading Co., Ltd.

2012/02/09 Greiner Bio-One 5ml Lithium Heparin Sep. Venous Blood Collection Tube Health Canada 70122 Type II Mekim Ltd

2012/02/09 Patterson Medical Supply, Inc. Bur U-Sharp Carbide FG Health Canada 70069 Type IIPatterson Medical

Supply, Inc.

2012/02/10

Steris Corporation STERIS SYSTEM 1E Liquid Chemical Sterilant Processing

System, Model/Part no.: Model P6500 FDA Z-0869-2012 Class IISwedish Trading Co.

Ltd.

2012/02/10Vision-Sciences, Inc. 1) Vision Sciences Battery Charger, Lithium Ion

2) Vision Sciences Rechargeable Lithium Ion Batteries, Replacement (2)FDA Z-0928-2012 to Z-0929-2012 Class II N.A.

2012/02/10

Alere San Diego Alere Cholestech LDX Analyzer, Model/Part no.: 10-004, 14-

874, 14-875 FDA Z-0964-2012 Class II N.A.

2012/02/10 Hitachi Cobas c501/ 502 laboratory analyser MHRA MDA/2012/004 MDARoche Diagnostics

(Hong Kong) Ltd

2012/02/13 Handheld dental X-ray units FDA N.A.

Press

Release/MedWa

tch

N.A.

2012/02/13 BD PrepStain Vacuum Pump BD N.A. NA BD

2012/02/13 Boston Scientific Wingspan Stent System and Gateway PTA Balloon Catheter Boston Scientific N.A. NASynapse Therapeutic

Ltd.

2012/02/14 Salter Labs 7600 Bubble Humidifier, 350cc volume with 6PSI safety valve FDA Z-0803-2012 Class I N.A.













http://hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2012/ventilation_nth-aah-eng.php








http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm291373.htm;http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm291539.htm


2012/02/14 Varian VariSeed MHRA 2012/002/001/291/015 FSNVarian Medical Systems

Pacific Inc.

2012/02/14Nikkiso Octo Nova® HEMOFIL TRATION DEVICE (GE-F076-00, GE-F076-10,

GE-F090-00, GE-F091-00)MHRA 2012/002/007/081/002 FSN Baxter Healthcare Ltd

2012/02/14

Philips Healthcare Philips IntelliVue Patient Monitors: MP20 (M8001A), MP30

(M8002A), MP40 (M8003A), MP50 (M8004A), MP60 (M8005A), MP70

(M8007A), MP80 (M8008A), MP90 (M8010A), D80 (M8016A), MX600

(865242), MX700 (865241) MX800 (865240)

MHRA 2012/002/009/081/006 FSNPhilips Electronics

Hong Kong Ltd

2012/02/14 Ranier Technology Limited Cadisc-L total lumbar disc replacement MHRA 2012/002/006/291/013 FSNRanier Technology

Limited

2012/02/14Smith & Nephew Orthopaedics Ltd SpatialFrame.com software, product code

71070401, version 4.1.1MHRA 2012/002/006/081/007 FSN Smith & Nephew Ltd.

2012/02/14 Varian Medical Systems PaxScan 4336R power cable MHRA 2012/002/006/081/018 FSNVarian Medical Systems

Pacific Inc.

2012/02/14 CaridianBCT CaridianBCT Trima Accel® Disposable Tubing Sets MHRA 2012/002/008/081/004 FSNCaridianBCT (Hong

Kong) Ltd

2012/02/14 GE Healthcare mlBG-dilution set MHRA 2012/002/003/291/014 FSNGE Medical Systems

Hong Kong Ltd.

2012/02/14 Alcon Laboratories Ltd Alcon AcrySof® CACHET® Phakic Lens MHRA 2012/002/007/081/016 FSN Alcon Hong Kong, Ltd.

2012/02/14Beckman Coulter UK Ltd Floor Cabinet for UniCel DxH Slidemaker Stainer

Cellular Analysis SystemMHRA 2012/002/003/601/002 FSN


Kong Ltd

2012/02/14 Biomet UK Ltd AGC Patella Button 34mm MHRA 2012/002/002/291/036 FSN N.A.

2012/02/16 NEMSCHOFF Bassinet Models: BSNT/01; BSNT/02, BSNT/03, BSNT/04 FDA Z-0832-2012 Class I N.A.

2012/02/21Covidien Disposable imaging device accessories, Syringe, MR w/laternal flow

needle; Y Tubing, MR, with single check valve; Coiled Extension TubingMHRA 2012/002/016/081/010 FSN

Tyco Healthcare

(HKSAR) Ltd

2012/02/21Varian Dual Varian Clinac® accelerators with Mark or Millennium MLC and

BrainLAB m3 MLCMHRA 2012/002/015/081/005 FSN


Pacific Inc.

2012/02/21

Vascutek Anaconda and Anaconda ONE-LOK Stent Graft Systems (Model no.:

B19, B21, B23, B28, B30, B32, B34

)

MHRA 2012/002/016/291/005 FSNKeymax Technology

(HK) Ltd.

2012/02/21 The Helping Hand Company Hoist Turntable Mk 6 Part number RA8330 MHRA 2012/002/014/291/009 FSN N.A.

2012/02/21Thermo Fisher Scientific Oxoid Ready Poured Plate, PO0120A, CLED Agar,

Lot number 1200138.MHRA 2012/002/009/601/006 FSN

Thermo Fisher

Scientific (HK)

2012/02/21Thermo Fisher Scientific Oxoid Ready Poured Plate, PO0152A, Mueller Hinton

Agar (4mm depth), Lot number 1201920MHRA 2012/002/009/601/013 FSN

Thermo Fisher

Scientific (HK)

2012/02/21Hospira Inc. Lifecare™ 5000 IV Pump Set [0F8259701, 0G8689701,

0P7419701]MHRA 2012/002/015/081/001 FSN Hospira Limited

2012/02/21

Intuitive Surgical Inc Intuitive Surgical ® da Vinci S Surgical Systems [Model

no.: da Vinci S® Surgical System IS 2000, da Vinci Si® Surgical System IS

3000, da Vinci Si-e® Surgical System]

MHRA 2012/002/010/081/001 FSN Chindex

2012/02/21Ropox A/S Hudson Shower bed [Article: 40-25023-XX, 40-25026-XX, 40-

25029]MHRA 2012/002/001/291/005 FSN Ropox A/S

2012/02/21 Activate Ltd Corgi Class Chair MHRA 2010/003/023/401/012 FSN N.A.

2012/02/21 Balt Extrusion BALTACCI Infusion Catheters MHRA 2012/002/001/291/019 FSN N.A.

2012/02/21 Biosense Webster Inc Carto 3 Systems MHRA 2012/002/015/081/004 FSNJohnson & Johnson

Medical (HK)

2012/02/23 Sybron Dental Specialities Buchanan Medium PluggersSybron Dental

SpecialitiesN.A. FSN N.A.

2012/02/23Sybron Dental Specialities K3 Gutta Percha, Part No.: 825-0625 & Lot No.:

042511

Sybron Dental

SpecialitiesN.A. FSN Citicon (Hong Kong) Ltd

2012/02/24 Zimmer Natural-Knee II Durasul All-Poly Patella FDA Z-0848-2012 to Z-0855-2012 Class IIZimmer PTE Ltd. (Hong

Kong branch)

2012/02/24Beckman Coulter UK Ltd Clinical Chemistry Analyzers (AU400, AU600,

AU2700 and AU5400)FDA Z-0974-2012 to Z-0977-2012 Class II


Kong Ltd



























2012/02/24

Philips Medical Systems Software version 4.0 Beta 2 in

1) Brilliance 64 Computed Tomography System, Model #728231 and

2) Ingenuity CT computed Tomography System, Model #728326 FDA Z-0360-2012 to Z-0361-2012 Class II

Philips Electronics

Hong Kong Ltd

2012/02/24Allen Medical Systems, Inc. Allen C-Flex Head Positioning System [Catalog

No.:A-70700 and A-70701-2]FDA Z-0655-2012 Class II

Allen Medical Systems,

Inc.

2012/02/24Biomet Microfixation, Inc. IQ SYSTEM IQ INTELLIGENT DRIVER 16.51CM

(6.5")(L) RABALON, STAINLESS STEEL, GOLD PLATEDFDA Z-0447-2012 Class II N.A.

2012/02/28Sorin CRM SonRtip endocardial pacing lead with contractility sensor,

Model/Part no.: PS55DMHRA 2012/002/023/291/005 FSN

Innotronik Hong Kong

Limited

2012/02/28Roche Diagnostics GMBH Troponin I Elecsys cobas e, Troponin I STAT

Elecsys cobas e 100MHRA 2012/002/021/291/009 FSN

Roche Diagnostics

(Hong Kong) Ltd

2012/02/28 Roche Diagnostics GMBH cobas c-pack MULTI MHRA 2012/002/016/081/014 FSNRoche Diagnostics

(Hong Kong) Ltd

2012/02/28 Abbott Point of Care Inc i-STAT cTnI, BNP, and CK-MB cartridge MHRA 2012/002/021/081/006 FSN


Ltd., Abbott

Laboratories Ltd.

2012/02/28Aesculap AG/ B Braun S4 Cervical Occiput Screw Remover, S4 Cervical

Occiput Screw Removal ShaftMHRA 2012/002/023/291/006 FSN N.A.

2012/02/28 Bard Limited MRI Implanted Port MHRA 2012/002/020/081/018 FSNSenrex International

Ltd.

2012/02/28 B Braun Medical Inc. SUSI instruments (various models and lots) MHRA 2012/002/020/081/020 FSNB. Braun Medical Hong

Kong

2012/02/28

Biomet UK Ltd Vanguard Tibial Resection Tower & Vanguard Distal Cut Block

Lot 2561334 and Lot 2561329]MHRA 2012/002/016/081/019 FSN N.A.

2012/02/28

GE Healthcare OEC® 9800, OEC® FluoroTrak 9800 Plus & OEC® 9800MD

Motorized C-arm System MHRA 2012/002/023/081/006 FSNGE Medical Systems

Hong Kong Ltd.

2012/02/28

Thoratec HeartMate II® Left Ventricular Assist System (HM II LVAS) Sealed

Outflow Graft Short Bend Relief (Catalog No. 104692) and Thoratec HeartMate

II Sealed Outflow Graft (Catalog No. 103393).

Firm initiated N.A. FSNTransmedic China

Limited

2012/02/29 Mizuho Orthopedic Systems Swivel Adapter Assembly, Headrest (Plastic) Health Canada 71131 Type II Keymax Technologies

2012/02/29Arrow International A) Epidural Catheterization Kit

B) Peripherally Inserted Central Catheter Seldinger Access KitHealth Canada 71094 Type II

Cemma Enterprise Co.,

Ltd

2012/02/29 Scottcare Corporation TeleSentry Model TS01 Health Canada 71132 Type II N.A.

2012/02/29Ortho-Clinical Diagnostics Inc. VITROS Chemistry Products dHDL Slides

(Model/Part no.: 680 1895, 680 2469)Health Canada 71324 Type II

Ortho Clinical

Diagnostics

2012/02/29 Immucor Inc. WBCORQC (Model/Part no.: 0066090, lot number: 236123) Health Canada 70667 Type III Uninet Technology Ltd.

2012/02/29 Beckman Coulter Inc. Access Hybritech Free PSA (Part no.: 37210) Health Canada 67750 Type IIIBeckman Coulter Hong

Kong Ltd

2012/02/29Beckman Coulter Inc. Manual Immunoassay DHEA RIA Test Kit (Part no.: DSL-

8900)Health Canada 71083 Type III


Kong Ltd

2012/02/29Beckman Coulter Inc. Flow-Set Fluorospheres (Part no.: 6607007; Lot number:

7524018F, 7524019F)Health Canada 71084 Type III


Kong Ltd

2012/02/29

Siemens Healthcare Diagnostics A) Rapidpoint 400 System

B) 850/855 Blood Gas System - Control Reagents

C) 840-845 Blood Gas System - Control Reagents

D) 348 System - Reagents

E) 860-865 Blood Gas System - Control Reagents

F) RapidQC Complete Level 1

G) RapidQC Complete Level 3


Diagnostic Limited






















2012/02/29

Life Technologies Corporation (Invitrogen) A) Invitrogen CW High Res Unitray

SSP Kits

B) Invitrogen Allset Gold SSP CW High Res Kits

Health Canada 71115 Type IIIInvitrogen Hong Kong

Limited

2012/02/29Alba Bioscience Limited FetalScreen II Fetal Maternal Hemorrhage Screening

TestHealth Canada 71080 Type III Alba Bioscience Limited

2012/02/29 Beckman Coulter, Inc. ACTIVE Aldosterone RIA Health Canada 71088 Type IIIBeckman Coulter Hong

Kong Ltd

2012/02/29

Beckman Coulter, Inc. A) Access Immunoassay System Access Accutni

Reagent

B) Unicel DXI 600 Access Accutni Reagent


Kong Ltd

2012/02/29 Contura International A/S Bulkamid Urethroscope Health Canada 71253 Type IIIContura International

A/S

2012/02/29Roche Diagnostics GMBH A) Tina-Quant IGG Gen2

B) Tina-Quant IGG Gen2Health Canada 71169 Type III

Roche Diagnostics

(Hong Kong) Ltd

2012/02/29 Becton Dickinson and Company BBL Lysine Iron Agar Health Canada 71099 Type III BD

2012/02/29

Siemens Healthcare Diagnostics Products Limited A) Immulite System CK-MB

Assay

B) Immulite 2500 System CK-MB Assay

C) Immulite System Turbo CK-MB Assay

D) Immulite 2000 System CK-MB Assay


Diagnostic Limited

2012/02/29

Siemens Healthcare Diagnostics Inc. A) 850-855 Blood Gas System - Control

Reagents

B) 840-845 Blood Gas System - Control Reagents

C) 348 System - Reagents

D) 860-865 Blood Gas System - Control Reagents

E) CVM Controls


Diagnostic Limited

2012/02/29

HowMedica Osteonics Corporation Partnership Definition PM Hip Stem -

Cemented (Model No.: 6265-3-101, 6265-3-102, 6265-3-103,

6265-3-104, 6265-3-105, 6265-3-106, 6265-3-107)


2012/02/29Stryker Orthopeadics Accolade RASP Handle (Model No.: 1020-1400; Lot

Number: P5E93)Health Canada 70655 Type II Stryker China Ltd

2012/02/29GE Medical Systems, LLC A) VMX Mobile X-ray, B) VMX Plus Mobile X-ray

SystemsHealth Canada 70843 Type II

GE Medical Systems

Hong Kong Ltd.

2012/02/29 Innovacon, Inc Innovacon Strep A Rapid Test Device (Throat Swab) Health Canada 69394 Type II N.A.

2012/02/29 Agfa Healthcare N.V. Impax for Cardiology- Clinical Review Station Health Canada 71095 Type IIAGFA Hong Kong

Limited

2012/02/29Enginivity LLC (a GE Healthcare company) Enflow IV Fluid/ Blood Warming

SystemHealth Canada 71100 Type II

GE Medical Systems

Hong Kong Ltd.

2012/02/29 Haag-Streit, AG Octopus 900 Basic, Octopus 900 Pro Health Canada 68860 Type II The VITA CO. Ltd.

2012/02/29 Beckman Coulter, Inc Coulter PrepPlus Health Canada 71085 Type IIBeckman Coulter Hong

Kong Ltd


















Date of Issue

(YYYY/MM/D

D)



Alert Type by

SourceLocal Agent

2012/01/03Biomet Orthopedics Discovery Elbow System Humeral Condyle Kit-

Hexalobular [Part No: 114700; Lot No: 797550]MHRA 2011/012/021/081/012 FSN N.A.

2012/01/03Beckman Coulter SYNCHRON System(s) Multi Calibrator Diskette (Ref No:

442648; Lot No: M002642G)MHRA 2011/012/020/601/008 FSN


Kong Ltd

2012/01/03GE Healthcare Definium 8000 and Discovery XR650 Patient Barrier (Ref: FMI

10856)MHRA 2011/012/021/081/014 FSN

GE Medical Systems

Hong Kong Ltd.

2012/01/03 GE Healthcare GE OEC Fluorostar 7900 (Ref: FMI 15116) MHRA 2011/012/022/081/013 FSNGE Medical Systems

Hong Kong Ltd.

2012/01/03 HeartWare Inc HeartWare Ventricular Assist System MHRA 2011/012/007/081/021 FSN HeartWare Inc

2012/01/03 Karl Storz Endoscopy (UK) Ltd Single-Use Gas Filter 031122-25 MHRA 2011/011/022/291/001 FSN

KARL STORZ

Endoscopy China Hong

Kong office

2012/01/03 Maquet Cardiovascular MAQUET HANAULUX G8 MHRA 2011/012/021/081/018 FSNMAQUET Hong Kong

Limited

2012/01/03 Spacelabs Healthcare Inc Ultraview SL Command Module MHRA 2011/012/019/081/002 FSNSchmidt Bio Med Tech

(H.K.)

2012/01/03St. Jude Medical Eon™ (Model 65-3716), Eon Mini™ (Model 65-3788) and

Brio™ (Model 65-6788) MHRA 2011/012/019/081/010 FSN


Kong) Ltd.

2012/01/03 Stryker Orthopaedics X-Change III Connector 0943-5-000 MHRA 2011/011/008/291/013 FSN Stryker China Ltd

2012/01/03 Stryker Orthopaedics TRIDENT 10 Degree Poly Inserts MHRA 2011/011/008/291/022 FSN Stryker China Ltd

2012/01/03 SynCardia Systems, Inc. Freedom Driver System 595000-001 MHRA 2011/012/019/291/002 FSN N.A.

2012/01/03Microgenics Corporation (Thermo Fisher Scientific) CardioImmune XL Cardiac

Marker Control, Level L, Level 1, Level 2, Level 3, Multi-pack, Sample Pack.MHRA 2011/012/020/081/023 FSN

Thermo Fisher

Scientific (HK)

2012/01/03 OptiMed GmbH Cemento Plus MHRA 2011/012/013/081/007 FSN N.A.

2012/01/03Philips Healthcare GEMINI TF 16 and GEMINI TF 64 PET/CT Systems

Software Versions 3.5.1 and 3.5.1.1MHRA 2011/008/031/401/008 FSN


Kong Ltd

2012/01/03RMS UK RES-Q-VAC Suction Unit with FSP (Bacteria) Fileter and Soft

YankauerMHRA 2011/010/025/081/002 FSN N.A.

2012/01/03Roche Diagnostics GmbH COBAS® TaqMan® HIV-1 Test, version 2.0 for use

with the High Pure System, CE-IVDMHRA 2011/012/015/291/021 FSN

Roche Diagnostics

(Hong Kong) Ltd

2012/01/03 Siemens Healthcare Diagnostics Ltd CLiNITEK Status System MHRA 2011/012/016/601/001 FSNSiemens Healthcare

Diagnostic Limited

2012/01/03 Thermo Fisher Scientific Oxoid M.I.C Evaluator Strips, Teicoplanin (MA0118) MHRA 2011/012/021/601/002 FSNThermo Fisher

Scientific (HK)

2012/01/03

Thomas Medical Products Thomas Medical Products: 1) 7F SafeSheath

Tearaway Kit – 13cm; 2) 9F SafeSheath Tearaway Kit – 13cm; 3) Transvalvular

Insertion Tool Kit; 4) SafeSheath® Sealing Adapter Kit; 5) SafeSheath® Sealing

Adapter Kit with Wing Extension Kit


Hong Kong Ltd.

2012/01/03TRUMPF Medical Systems Sterilisable Handle ALC in Surgical lighting systems

iLED and TruLight (Material number: 1583966)MHRA 2011/012/019/601/001 FSN N.A.

2012/01/03Varian Varian Treatment versions 6.6.5034, 6.6.5042, 6.6.5046, 6.6.5048,

6.6.5051 and 6.6.5052MHRA 2011/012/013/081/004 FSN


Pacific Inc.

2012/01/05Philips Healthcare All Brilliance CT Big Bore systems having the software

versions 3.5.0.17401 and 3.5.1.17002MHRA 2011/012/022/291/004 FSN


Kong Ltd

Major Safety Alerts in January 2012


























2012/01/05 Siemens Healthcare Diagnostics Ltd Dimension Vista® Software Version 3.4 MHRA 2011/012/021/601/003 FSNSiemens Healthcare

Diagnostic Limited

2012/01/05 Ikaria Ikaria INOmax DS Drug Delivery System FDA N.A. Class I N.A.

2012/01/06 Wallac PerkinElmer Genetic Screening Processor (GSP 2021-0010) FDA Z-0603-2012 Class II N.A.

2012/01/10 Columbia Medical Ultimate Bath Chair H88489, H88519 and H88521 MHRA 2010/005/021/401/008 FSN N.A.

2012/01/10

Oridion Medical Surestream CO2 Sampling Lines: SureLine Adult, SureLine

Pediatric, SureVentLine, Sure VentLine H Set, SureLine O2 Adult (Part

Numbers 010976, 010977, 010986, 010987, 010979)

MHRA 2011/009/016/401/011 FSN N.A.

2012/01/10 QIAGEN GmbH 8-Rod Covers (Lot No. CH_1104624 and CH_1105182) MHRA 2011/012/020/081/013 FSN N.A.

2012/01/10Sybron Dental Specialities Vector TAS Modular Driver (601-0007) and Vector

TAS Kit (includes 1 Vector TAS Modular Driver) (601-0010)MHRA 2012/001/005/121/012 FSN N.A.

2012/01/10 SynCardia Systems, Inc. SynCardia Companion 2 Driver System MHRA 2011/012/022/081/009 FSN N.A.

2012/01/10ArjoHuntleigh Lifeguard® LG20 and LG50 patient trolleys (stretchers) ; [Serial

Numbers: P064867 to P100186 inclusive]MHRA 2011/006/027/601/001 FSN

Arjo Huntleigh (Hong

Kong) Ltd.

2012/01/10 DiaMed GmBH IH-1000 [Product REF: 001000V; Software version: 01.03.04] MHRA 2011/012/030/081/002 FSN Bio-Rad Pacific Ltd.

2012/01/10DePuy International Ltd DePuy Universal Femoral Sleeve Distal Porous 34 MM

[Model No.: 129453225; Lot numbers: 115369 and 115369A]MHRA 2012/001/005/181/004 FSN

Johnson & Johnson

(Hong Kong) Ltd.

2012/01/10 Haemonetics Corporation Haemonetics cardioPAT® MHRA 2011/009/009/081/011 FSNHaemonetics (Hong

Kong) Limited

2012/01/10Johnson & Johnson Medical Ltd ACUVUE® OASYS® (senofilcon A) Brand

Contact LensesMHRA 2011/012/030/081/003 FSN

Johnson & Johnson

(Hong Kong) Ltd

2012/01/10 Instrumentation Lab (UK) Ltd ACL TOP® Family MHRA 2011/011/030/401/006 FSN Vastec Medical Limited

2012/01/10Newdeal Integra Life Pre-Amp Transducer Cable for the Camino® Advanced

Monitor (CAM01) and the Multi-Parameter Monitor (MPM1) Part Number: PAC1 MHRA 2011/010/021/081/014 FSN N.A.

2012/01/12Professional Disposables International PDI Electrode Prep Pads in Spacelabs

Hook-up kitsFDA Z-0262-2012 Class II N.A.

2012/01/12PerMedics, Inc. Odyssey A radiation treatment planning system (Versions 4.4

through 4.7)FDA Z-0345-2012 Class II N.A.

2012/01/12 Midmark Corp Midmark M11 Ultra Steam Sterilizer FDA Z-0597-2012 Class IIAssociated Medical

Supplies Company, Ltd.

2012/01/12

Siemens Healthcare Diagnostics, Inc (1) Dimension(R) Vista(R) V-LYTE(R)

Standard A (K820), (2) Dimension(R) Vista(R) V-LYTE(R) Standard B/Salt

Bridge (K825), (3) Dimension(R) Vista(R) V-LYTE(R) Diluent (K835)

FDAZ-0644-2012, Z-0645-2012, Z-

0646-2012Class II

Siemens Healthcare

Diagnostic Limited

2012/01/12 Spacelabs Healthcare Lifescreen ECG Screening System V3 FDA Z-0520-2012 Class IISchmidt Bio Med Tech

(H.K.)

2012/01/12Given Image Bravo® pH Monitoring System, part number FGS‐0312 (5‐Pak) or

FGS‐0313 (Singles)Firm initiated N.A. NA

Given Imaging (Asia)

Company Ltd.

2012/01/13 Respironics Inc Respironics Trilogy 100 ventilators FDA N.A. Class I Celki Medical Company

2012/01/13Terumo CVS Modified cable to connect the system to an occluder for the Sarns

Modular Perfusion System 8000Firm initiated AA-2011-013-C NA

TERUMO CHINA (H.K.)

LTD.

2012/01/13Covidien PTE Ltd DUET TRS Universal Straight and Articulating Single Use

Loading Units (SULU) Firm initiated N.A. NA

Covidien Hong Kong

Ltd

2012/01/17 Stryker Orthopaedics Acetabular Reamer 44mm (Catalogue no. 2102-0444) MHRA 2012/001/011/081/010 FSN Stryker China Ltd

2012/01/17 Stryker Orthopaedics XIA 3 ANTI TORQUE KEY (Catalogue no. 48237026) MHRA 2012/001/005/121/004 FSN Stryker China Ltd

2012/01/17Leica Primary antibodies to CD4 (clone1F6), CD7 (clone LP15), Estrogen

Receptor (clone 6F11)MHRA 2012/001/010/601/008 FSN Leica Microsystems Ltd.

2012/01/17Natus Medical Incorporated ABaer® Hearing Screener with software version

5.0.17 or lowerMHRA 2012/001/010/081/016 FSN N.A.

2012/01/17NIHON KOHDEN NIHON KOHDEN Amp Units (JB-116B and JB-132B and

Extension Unit MS-110B) used for Neuromaster MEE-1000A MHRA 2012/001/010/081/008 FSN N.A.





















http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm287575.htm; http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm287528.htm






2012/01/17Cefndy Healthcare (Rhyl) Cefndy Healthcare X220 & X221 (including X312 &

X313) Bariatric CommodesMHRA 2009/011/017/081/018 FSN

Cefndy Healthcare

(Rhyl)

2012/01/17

Fisher and Paykel Healthcare Ltd Fisher & Paykel Healthcare PT100

(myAIRVO) & PT101 (AIRVO) units [Part no.: PT100UK & PT101UK; Affected

lot number: 080101-110420]

MHRA 2011/012/005/081/001 FSNFisher & Paykel

Healthcare Limited

2012/01/17

Karomed Ltd Karomed’s static mattresses and overlays [Product Model:

Transfoam, Transvisco, Transwave Supreme and Transvalue mattresses and

the Transvisco and Transpad overlay]

MHRA 2010/007/005/401/002 FSN Karomed Ltd

2012/01/17 Abbott ARCHITECT Active-B12 (Holotranscobalamin) MHRA 2012/001/006/601/001 FSN Abbott Laboratories Ltd.

2012/01/17 Alere Triage® 8 Panel for Drugs of Abuse Test Kit MHRA 2012/001/012/081/002 FSN N.A.

2012/01/17 Axis-Shield poC AS Afinion™ CRP (REF 1115013 and 1115014) MHRA 2012/001/010/081/010 FSN N.A.

2012/01/19 Agfa Corp. Agfa Computed Radiography Systems with DX-G Digitizer FDA Z-0591-2012 Class IIAGFA Hong Kong

Limited

2012/01/19

ConMed Corp. STAT2 I.V. Controller, Extension Set Gravity Flow Controller,

Primary Administration Set Gravity Flow Controller, Secondary Set Gravity Flow

Controller

FDAfrom Z-0629-2012 to Z-0635-

2012 Class II

Goodmark Medical

Supplies Ltd

2012/01/19Biomet Inc. Biomet Series A Thin Patella, Standard Patella, and Asymmetrical

PatellaFDA

from Z-0695-2012 to Z-0704-

2012 Class II N.A.

2012/01/19GE Healthcare Ge LOGIQ E9 Diagnostic Ultrasound Systems running software

versions R3.1.0 and R3.1.1.FDA Z-0705-2012 Class II

GE Medical Systems

Hong Kong Ltd.

2012/01/19Philips Medical Systems (Cleveland) Inc. SKYlight Imaging Systems, Model

882050FDA Z-0607-2012 Class II


Kong Ltd

2012/01/20Siemens Healthcare Diagnostics Dade Actin FSL Activated PTT Reagent

(Model no. B4219-1, B4219-2)Health Canada 70183 Type II

Siemens Healthcare

Diagnostic Limited

2012/01/20 GE Healthcare Patient Data Module (Model no. PDM-XXX-XXX-XXXX) Health Canada 69525 Type IIIGE Medical Systems

Hong Kong Ltd.

2012/01/20Ethicon Endo-Surgery Endopath ETS45 Endoscopic Linear Cutter (Model no.

ETS45)Health Canada 69531 Type III

Johnson & Johnson

(Hong Kong) Ltd.

2012/01/20 Seradyn Inc. Tobramycin Calibrators (Model no. 7F93-01) Health Canada 69168 Type IIIThermo Fisher

Scientific (HK)

2012/01/20

Baxter Healthcare SA A) Acute Renal Dialysis Machine Aquarius System

(Model no. GEF09700);

B) Acute Renal Dialysis Machine Aquarius System - Platinum Software (Model

no. GEF08200)

Health Canada 69529\ Type III Baxter Healthcare Ltd

2012/01/20 Sorin Group Italia S.R.L. Cardiovascular Oxygenator Custom Packs Health Canada 69942 Type IIInnotronik Hong Kong

Limited

2012/01/20 Siemens AG Mevatron Linear Accelerator Health Canada 69949 Type IISiemens Healthcare

Diagnostic Limited

2012/01/20Philips Medical Systems (Cleveland) Inc. Skylight Gamma Camera System

(2160-3000A)Health Canada 69952 Type II


Kong Ltd

2012/01/20 Beckman Coulter Coulter ACT 5diff Fix Reagent (8547171) Health Canada 70194 Type IIBeckman Coulter Hong

Kong Ltd

2012/01/20 Coopersurgical Inc Tis-U-Trap with Cannula-Curette Health Canada 70263 Type IIAnchor Medical

Services

2012/01/20Beckman Coulter Inc. Access Total T3 Reagent


Kong Ltd

2012/01/20

Ortho-Clinical Diagnostics Inc. Vistros Chemistry Products IGM Reagent and

Vistros Chemistry Products Vanc Reagent Health Canada 70181 Type IIIOrtho Clinical

Diagnostics

2012/01/20 Toshiba Medical Systems Corporation RADEX-1 Health Canada 70234 Type IIISanko Medical Systems

(HK) LTD

























2012/01/20

Roche Diagnostics GMBH Online TDM Theophylline (HIT. 911, 912, 917 and

MOD.P.) and Cobas Integra Theophylline for Cobas C Systems Health Canada 70082 Type IIIRoche Diagnostics

(Hong Kong) Ltd

2012/01/20

Biomet Microfixation, Inc. Sternalock Blu Implant Tray [Model No.: 73-1300, 73-

1301, 73-1302; Lot No.: 032211, 042911, 100611, 249640, 280130, 280131,

312560, 031411, 011411]

Health Canada 69661 Type I N.A.

2012/01/20Siemens AG Artis Zee Multi-Purpose [Model No.: 10094139; Serial Number

157633]Health Canada 70411 Type I

Siemens Healthcare

Diagnostic Limited

2012/01/20HowMedica Osteonics Corporation Triathlon Mobile Bearing Knee Surgical

ProtocolHealth Canada 69276 Type II Stryker China Ltd

2012/01/20

Sorin Group Italia S.R.L. A) Ecc. O. Integrated Mini Bypass System with

Preconnected Tubing

B) Primo2x Oxygenator w Intergrated Hardshell Venous Reservoir

C) Synthesis Oxygenator w Heat Exchanger Arterial Filter and Venous

Reservoir

D) D903 Avant 2 Adult Hollow Fiber Oxygenator

E) Synergy Adult Intergrated Mini Bypass System

F) D905 EOS Pediatric Hollow Fiber Oxygenator

G) D905 Module Pediatric Hollow Fiber Oxygenator

H) Apex HP Phisio Smart Hollow Fiber Membrane Oxygenator

I) D903 Oxygenator Perfusion Tubing Pack Phisio or Non Phisio Coated w

Oxygenator

J) Primo2X Oxygenator Perfusion Tubing Pack Phisio or Non Phisio Coated w

Oxygenator

K) Synthesis Oxygenator Perfusion Tubing Pack Phisio or Non Phisio Coated w

Oxygenator

L) Synthesis Oxygenator Perfusion Tubing Pack Phisio Coated w Oxygenator

M) D901 Oxygenator Perfusion Tubing Pack Phisio Coated w Oxygenator

N) D902 Oxygenator Perfusion Tubing Pack Phisio Coated w Oxygenator

Health Canada 69647 Type IIInnotronik Hong Kong

Limited

2012/01/20Integra Lifesciences Corporation DBA Integra Lifesciences Non-Sterile Step

Down Connector [Model No.: NL8600401]Health Canada 69651 Type II Milverton Limited

2012/01/21

Carefusion Nicolet® Cortical Stimulator Control Unit, Nicolet® C64 Stimulus

Switching Unit (SSU) Amplifier and NicoletOne Software with Cortical

Stimulator License

FDA N.A. Type ICareFusion Hong Kong

Ltd.

2012/01/26

Varian Eclipse Release 10 with ARIA™ Radiation Oncology (RT Chart module)

Release 10 (Client Build 10.0.28 or Build 10.0.34) MHRA 2012/001/013/291/009 FSNVarian Medical Systems

Pacific Inc.

2012/01/26 Beckman Coulter UK Ltd Active Renin IRMA Test Kit DSL-25100 MHRA 2012/001/017/601/002 FSNBeckman Coulter Hong

Kong Ltd

2012/01/26 Biomet UK Ltd Oxford revision stem MHRA 2012/001/017/081/011 FSN N.A.

2012/01/26Coloplast A/S Connectable Radio-Opaque Pusher CH/FR 07/ 40cm REF

YN2867 included in various kits-mainly ureteral stentsMHRA 2012/001/017/081/002 FSN

Coloplast (Hong Kong)

Ltd

2012/01/26Smith & Nephew Orthopaedics Ltd Smith & Nephew Endoscopy Dyonics Power

ll Control Unit (Product code:72200873)MHRA 2012/001/018/291/004 FSN Smith & Nephew Ltd.

2012/01/26 Stryker Osteosynthesis T2 Arthrodesis Nail (left and right version) MHRA 2012/001/016/081/018 FSN Stryker China Ltd

2012/01/26 Transonic Systems Inc COstatus AV Loop [Model/Part no.: HCS3011] MHRA 2012/001/017/081/020 FSN Transonic Systems Inc

2012/01/30

Henry Schein, Inc. a) Maxcem Elite(TM) self-etch/self-adhesive resin cement,

Refill Kit, net wt. 10 g, REF/Part # 33872; b) CLEAR --- Refill Kit Contents: 2

Syringes (5 g ea), 10 Automix tips (regular) 4:1, 10 Automix tips (wide) 4:1, 10

Intra-oral tips Dental resin cement.FDA Z-0390-2012 Class II Henry Schein, Inc.
















2012/01/30

Varian Portal Vision, R-Arm with 4D Integrated Treatment Console [Model/Part

no.: H80, H81] FDA Z-0516-2012 Class IIVarian Medical Systems

Pacific Inc.

2012/01/30ICU Medical, Inc Orbit and Orbit Micro Subcutaneous infusion set and IV Start

Kits Convenience kitFDA Z-0592-2012, Z-0593-2012 Class II N.A.

2012/01/30 Carefusion NicVue Software version 2.9.2 and 3.0.1 FDA Z-0737-2012 Class IICareFusion Hong Kong

Ltd.

2012/01/31Radiometer Medical APS ABL80 FLEX Analyzers configured with either FLEX

or BASIC softwareMHRA 2012/001/025/291/001 FSN

Radiometer China

(RCHN)

2012/01/31 Siemens Healthcare Diagnostics Syringes for BEP® III MHRA 2012/001/020/601/009 FSNSiemens Healthcare

Diagnostic Limited

2012/01/31 Leica Primary antibodies to CD2 (clone 11F11) and CD7 (clone LP15) MHRA 2012/001/026/601/002 FSN Leica Microsystems Ltd.

2012/01/31

Coloplast A/S Speedicath Compact CH10 female catheters [Model/Part no.:

285800; Affected lot number: 2846651] MHRA 2011/010/010/081/013 FSNColoplast (Hong Kong)

Ltd

2012/01/31 COMINOX s r l Strerilclave 6B Speedy MHRA 2011/007/025/291/030 FSN COMINOX s r l

2012/01/31 Elekta XVI R4.5 and R4.6 without iGuide ® MHRA 2012/001/025/291/002 FSN Elekta Ltd

2012/01/31

Cardiac Science Powerheart 9300A, 9300E, 9300P, 9390A, and 9390E;

CardioVive 92532 and 92533 (manufactured between July 1, 2011 and

December 30, 2011)

MHRA 2012/001/023/081/010 FSNPacific Medical Systems

Ltd

2012/01/31Adin Dental Implant Systems Ltd Retaining Screw for TMATM WP/RP/NP

Trans Mucosal Abutment System 3mmMHRA 2012/001/017/081/018 FSN N.A.

2012/01/31Beckman Coulter UK Ltd AU2700/AU2700 Plus & AU5400 Clinical Chemistry

AnalyzersMHRA 2012/001/024/601/006 FSN


Kong Ltd

2012/01/31 Biomet 3i Certain® Low Profile 17ﾟAngled Abutment MHRA 2012/001/023/081/008 FSN Ositek (HK), Inc. Ltd














major safety alerts in september 2012 - mdco.gov.hk · description of product source of...

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