safety communication action required - sfda.gov.sa alerts/(sg-1810-21... · unimed has initiate a...

SG-1811-21-H 11/01/2018

Safety Communication – Action Required If you have the products mentioned below, you should respond to this notification

Urgent notification about Recall of surgical Sutures manufactured by UniMed

Device/ Product Name: Surgical Sutures

Lot numbers/Serials: Multiple models and Lots (attached) Click here for information

Manufacturer: United Medical Industries Co. Ltd. (Unimed)

Problem:

Saudi FDA would like to bring to your attention that UNIMED has initiate a recall for Multiple models and Lots From Surgical Sutures. The manufacturer has identified that the sutures breaking strength are non-compliant to European Pharmacopeia requirements.

Recommendation/Actions:

1. Cease the affected lots and quarantine the

remaining quantities. 2. Share this information with concern departments in

your hospital. 3. contact SFDA in case you have any quantity from

the affected lots. 4. Report any incident/ adverse events suspected to

be associated with affected products to Saudi FDA.

http://ncmdr.sfda.gov.sa/Secure/CA/CaCompositeListing.aspx

http://www.sfda.gov.sa/en/Pages/default.aspx

https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=10223

SG-1811-21-H 11/01/2018

Example for the affected

Product:

Healthcare Professionals should report any adverse events suspected to be associated with affected devices above (or other Medical Devices) to:

National Center for Medical Devices Reporting. Medical Devices Sector Saudi Food and Drug Authority Postal Address: Saudi Arabia - Saudi Food and Drug Authority (3292) North Ring Road - Al Nafal Unit (1) Riyadh 13312 - 6288 Tel: +966 (11) 2038222 Ext: 2406, 2412 Fax: +966 (11) 2757245

For latest published Recalls/Alerts, please visit (NCMDR Website) Sincerely, NCMDR Team


http://www.sfda.gov.sa/en/Pages/default.aspx

http://ncmdr.sfda.gov.sa/Default.aspx


UNI®

Head Office P.O.Box 51871Riyadh 11553 Saudi ArabiaTel: +966 11 265 0665Fax: +966 11 265 [email protected]

United Medical Industries Co. Ltd.

Urgent Field Saftey NoticeUnicryl Surgical Suture

Date: 13/1112016Unimed Reference: FSN01Dear NCMDR TeamThis letter to inform you that we have identified that the Suture Breaking Strength in few incidents are

non compliant to European Pharmacopeia requirements.

We are initiating a voluntary recall for the following batches:

Serial Bateh# Item Code Oeseription

1 10777-06 OW8902U Unieryl (ud) 19mm eurv.eutt. 2(3/0) 75em

2 10943-41 OW8902RU Unieryl (ud) 19mm eurv.rev.eutt. 2(3/0) 75em


4 10705-16 OW8832R5U7 Unieryl (ud) 26mm eurv.rev.eutt. 2(3/0) 75em

5 11026-28 OW8833R57U Unieryl (ud) 26mm eurv.rev.eutt. 3(2/0) 75em --6 11130-02 OW8833RS7U Unieryl (ud) 26mm eurv.rev.eutt. 3(2/0) 75em--7 10705-17 OW8833R57U Unieryl (ud) 26mm eurv.rev.eutt. 3(2/0) 75em --8 10831-01 OW8572U Unieryl (ud) 60mm str.cutt. 2(3/0) 75em

9 11043-01 OW8572U Unieryl (ud) 60mm str.eutt. 2(3/0) 75em

10 11024-01 OW8759R Unieryl13mm eurv.rev.eutt. 0.7(6/0) 45em

11 11118-16 508214 Unieryl18mm eurv.eutt 1(5/0)75em --12 10754-01 OW8900R5 Unieryl19mm eurv.rev.eutt. 1(5/0) 45em

13 11090-37 OW8921 Unieryl 20mm 1/2e.r.b. 1.5(4/0) 75em

14 10850-49 OW8921 Unieryl 20mm 1/2e.r.b. 1.5(4/0) 75em---

15 10850-33 OW8921 Unieryl 20mm 1/2e.r.b. 1.5(4/0) 75cm -16 10850-49 OW8921 Unieryl 20mm 1/2e.r.b. 1.5(4/0) 75em --17 10841-23 5E 540 Unieryl 22mm 1/2e.r.b. 1.5(4/0) 75em --18 10878-01 59890 Unieryl 22mm 1/2e.r.b. 3(2/0) 75em

19 10841-18 OW89375 Unieryl 24mm eurv.eutt. 2(3/0) 75em

20 10841-14 OW8938 Unieryl 24mm eurv.eutt. 3(2/0) 70em --21 10705-19 0'11.'8942 Unieryl 26mm 1/2e.r.b. 2(3/0) 75em

22 11148-04 OW8942 Unieryl 26mm 1/2e.r.b. 2(3/0) 75em"--

23 10879-12 OW8942 Unieryl 26mm 1/2e.r.b. 2(3/0) 75em


25 10706-33 OW8943 Unicryl 26mm 1/2e.r.b. 3(2/0) 75em

26 10943-29 OW8943 Unieryl 26mm 1/2e.r.b. 3(2/0) 75em -----27 10777-14 OW8943 Unicryl 26mrn 1/2e.r.b. 3{2/0) 75em --28 10900-03 508300 Unieryl 26mm 5/8e.r.o.3(2/0) 75em

UNI®

Head Office P.O.Box51871Riyadh 11553 Saudi ArabiaTel: +966 11 265 0665Fax: +966 11 265 [email protected]


29 11127-01A DW8833 Unieryl 26mm eurv.eutt. 3(2/0) 75em

30 10850-47 DW8832R5 Unieryl 26mm eurv.rev.eutt. 2(3/0) 45em


32 10846-40 DW8952 Unieryl 30mm 1/2e.r.b. 2(3/0) 75em




36 10994-02 DW8954 Unieryl 30mm 1/2e.r.b. 3.5(0) 75em

37 10841-02 DW8954 Unieryl 30mm 1/2e.r.b. 3.5(0) 75em ----38 10879-28 DW8954 Unieryl 30mm 1/2e.r.b. 3.5(0) 75em

39 11090-45 DW8955 Unieryl 30mm 1/2e.r.b. 4(1) 75em --40 10841-06 DW8955 Unieryl 30mm 1/2e.r.b. 4(1) 75em

41 10841-15 DW881357 Unieryl 30mm eurv.cutt. 3(2/0) 75em

42 11127-03A 5D8668 Unieryl 35mm eurv.eutt. 3.5(0) 75em --43 11222-03 5D8668 Unicryl 35mm eurv.cutt. 3.5(0) 75em .,44 10801-08 5D8163 Unieryl 3Smm j.r.b. 4(1) 75em

~

45 10841-07 S 989359 Unieryl 37mm 1/2e.r.b. 4(1) 90em --46 10841-22 5D8665 Unicryl 37mm eurv.eutt. 3(2/0) 75em

47 10850-19 DW8525 Unieryl 40m~ 1/2e.eutt. 4(1) 75em- '---148 10890-01 DW85265 Unieryl 40mm 1/2e.elltt. 5(2) 70em ------.49 11154-01 DW8513 Unieryl 40mm 1/2e.r.b. 3(2/0) 75em

I

- ----------j50 10879-09 DW8513 Unieryl 40mrn 1/2e.r.b. 3(2/0) 75cm~ --_.•..•_----,,51 1031062K DW8514 Unieryl 4:Jmm 1/2e.r.h. 3.5(0) 7Scm

~. ------52 10370-62J DW8514 Unieryi 40mm 1/2e.r.b. 3.5(0) 75em -------53 10370-62N DW8514 Unieryl 40mm 1/2e.r.b. 3.5(0) 75em ----54 10370-62L DW8514 Unieryl 40mm 1/2e.r.b. 3.5(0) 75em --_._--55 11101-61E DW8514 Unieryl 40mm 1/2e.r.b. 3.5(0) 75em

56 11101-G1F DW8S14 Unieryl40mm 1/2e.r.b. 3.5(0) 75em ---~

I 57 10706-20 DW8514 Unieryl40mm i/zc.r.». 3.5(0) 75cm

58 10988-16A DW3514 Unieryl 40mrT] 1/2c.r.b. 3.5(0) 75em

.~59 10988-16 DW8514 Unieryl 40mm 1/2e.r.b. 3.5(0) 75cm

60 10777-J_2 DW8514 Unicryl 40mm 1/2e.r.b. 3.5(0) 75em

61 11205-0S DW85145 Unieryl 40mm 1/2e.r.b. 3.5(0) 90em,I

62 10706-21 DW8515 Unieryl 40mm 1/2e.r.b. 4(1) 75em-- '---'---J

- --...'.--..--~63 10846-43 DW8515 Unieryl 4Qmrn 1/2e.r.b 4(1) 75ern

~

i--

64 10705-13 DW8515 Unieryl 40rnm 1/2e.r.b. 4(1) 75em-

65 10887-22A DW8515 Unieryl 40mm 1/2e.r.b. 4(1) 75em

66 10879-01 DW8515 Unieryl40mrn 1/2e.r.b. 4(1) 75em I67 11044-15 DW8516 Unicryl 40mm 1/2e.r.b. 5(2) 75em

j1----68 10943-31 DW8516 Ur:ieryl 40mm 1/2c.r.b. 5(2) 75em

[ 69 10988-17 DW8516 Unieryl40mm 1/2e.r.b. 5(2) 75em

70 10850-20 DW8516 Unieryl4Cmm 1/2e.r.b._~_2) 75em--

UNI®



71 11116-33 DW8514H Unicryl 40mm 1/2c.r.b.hvy. 3.5(0) 75cm

72 11175-38 DW8524R Unicryl 40mm 1/2c.rev.cutt. 3.5(0) 75cm

73 10943-32 DW8525R Unicryl 40mm 1/2c.rev.cutt. 4(1) 75cm

74 10826-05 DT8415H Unicryl40mm 1/2c.taper.cut.hvy. 3(2/0) 75cm

75 11121-028 5D8189 Unicryl 40mm curv.cutt. 4(1) 75cm

76 10904-01 DW8854 Unicryl 45mm 1/2c.r.b.hvy. 3.5(0) 75cm -77 10826-02 DW8855 Unicryl 45mm 1/2c.r.b.hvy. 4(1) 75cm

78 10826-03 DW8856 Unicryl 45mm 1/2c.r.b.hvy.5(2) 75cm

79 10846-47 DW8856 Unicryl 45mm 1/2c.r.b.hvy.5(2) 75cm --80 10777-09A 5D8070 Unicryl 48mm 1/2c.cutt. 4(1) 75cm

81 11118-22 5D8070 Unicryl 48mm 1/2c.cutt. 4(1) 75cm

82 10850-29 SD8118 Unicryl 48mm 1/2c.r.b. 3.5(0) 90cm

83 10879-07 5D8118 Unicryl 48mm 1/2c.r.b. 3.5(0) 90cm

84 10879-05 59849 Unicryl48mm 1/2c.r.b. 4(1) 75cm

~85 10850-32 59849 Unicryl48mm 1/2c.r.b. 4(1) 75cm

86 10841-09 SD8061 Unicryl48mm 1/2c.r.b. 4(1) 90cm 187 10879-06 DW8554 Unicryl 50rnm 1/2c.r.b. 3.5(0) 75cm =188 10841-20 DW85715 Unicry! 60mmstr.cutt. 1.5(4/0) 67cm I

.----.89 10841-21 DW8573 Unicryl 60mm str.cutt. 3(2/0) 75cm

90 10777-13 DW8573 Unicryl 60mm_str.cutt. 3(2/0) 75cm

91 10841-19 DW8627D Unicryl 6mm curv.spat.d/a 0.4(8/0) 30cm

92 10839-13 DW8628D5 Unicryl 6mm curv.spat.d/a.0.5(7/0) 45cm

93 11090-28 DW8504 Unicryl cut lengths 3.5(0) 1.5m_. --94 11174-10 DW8505 Unicryl cut lengths 4(1) 1.5m- ----95 11044-12 DW8503 Unicryi cut lengths 3(2/0) 1.5 metres_. ---j

~10708-04 DW8503 Unicryl cut lengths 3(2/0) 1.5 metres

--~97 10841-16 DW8503 Unicryl cut lengths 3(2/0) 1.5 metres-98 10423-37 DW88605U Unicryl (ud) 16mm curv.cutt. 1(5/0) 45cm I- ,

I

99 10500-36 DW88615U Unicryl (Lid) 16mm curv.cutt. 1.5(4/0) 45cm ---_.-100 10501-01 DW88615U Unicryl (ud) 16mm curv.cutt. 1.5(4/0) 45cm- --101 10308-11 DW8861RU Unicryl (ud) 16mm curv.rev.cutt. 1.5(4/0) 75cm- --102 10308-10 DW8860RU Unicryl (ud) 16rtnn r.urv.rev.cutt.1(5/0) 75cm --_.__._-103 10523-01 DW8900U Unicryl (ud) 19mm curv.cutt. 1(5/0) 75cm --104 10267-73 DW89015U Unicryl (ud) 19011mcurv.cutt. 1.5(4/0) 45cm

105 10523-02 DW8901U Unicryl (ud) 19mm curv.cutt.I.Sla/O) 75cm

106 10633-16 DW890lU Unicryl (ud) 19mm curv.cutt.1.5(4!0) 75cm -----107 10140-8C DW8937RU Unicryl (ud) 24mrn curv.rev.cutt. 2(3/0) 75cm

108 10267-54 DW8832R5U7 Unicry! (ud) 26mm curv.rev.cutt. 2(3/0) 75cm I109 10011-07 DW8832RSU7 Unicryl (ud) 26mm curv.rev.cutt. 2(3/0) 75cm

110 10062-15 DW8833R57U Unicryl (ud) 26mm curv.rev.cutt. 3(2/0) 75cm .-.--~111 10174-68 DW8833R57U Unicryl (ud)26rnm curv.rev.cutt. 3(2/0) 75cm

-

UNI®

Head Office P.O.Box 51B71Riyadh 11553Saudi ArabiaTel: +966 11 265 0665Fax: +966 11 265 [email protected]


112 10267-74 DW8833R57U Unicryl (ud) 26mm curv.rev.cutt. 3(2/0) 75cm



115 10186-01 DW8881R Unicryl12mm curv.rev.cutt. 1.5(4/0) 75cm

Unicryl16mm 1/2c.r.b. 1 (5/0) 75cm I .-116 10389-12 DW8800

117 10331-01 DW8861 Unicryl16rnm curv.cutr. 1.5(4/0) 75crr.

118 10140-50 5D81145 Unicryl19mm 1/2c.eutt. 1.5(4/0) 75cm

119 10170-04 DW8902R Unieryl19mm curv.rev.cutt. 2(3/0) 70cm

J.20 10203-43 DW8902R Unicryl 19rnm curv.rev.cutt. 2(3/0) 70cm

121 10319-06 5E 663 Unicryl 20mm 1/2c.cutt. 1.5(4/0) 75cm

122 10112-11 5E 365 Unicryl 20mm 1/2c.cutt. 2{3/0) 75cm --123 10247-03 DW8921 Unicryl 20mm 1/2c.r.b. 1.5(4/0) 75cm

124 10062-17 DW8921 Unieryl 20mm 1/2c.r.b. 1.5(4/0) 75cm ----125 10140-53 DW8921 Unicryl 20mm 1/2c.r.b. 1.5(4/0) 75cm .126 10174-74 DW8921 Unicryl 20mm 1/2e.r.b. 1.5(4/0) 75cm --127 10500-26 DW8921 Unicryl 20mm 1/2e.r.b. 1.5(4/0) 75cm -----128 10518-02 DW8921 Unicryl 20mm 1/2c.r.b. 1.5(4/0) 75cm

129 10171-06 DW8922 Unicryl 20mm 1/2e.r.b. 2(3/0) 75cm .-130 10140-52 DW8922 Unicryl 20mm 1/2c.r.b. 2(3/0) 75cm

r--- --------131 10500-25 DW8922 Unieryl 20mrr. 1/2c.r.b.:,2(3/0) 75em .-132 10769-03 DW8922 Unicryl 20mm 1/2e.r.b. 2(3/0) 75cm ----_.133 10469-01 DW8922 Unicryl 20mm 1/2e.r.b. 2{3/0) 75cm

134 10062-19 ~8937R Unicryl 24mm curv.rev.cutt. 2(3/0) 70cm ---_.j135 10174-76 DW8937R Unicryl 24mm curv.rev.cutt. 2(3/0) 70cm

136 10137-03 DW8942 Unicryl 26r,1m 1/2c.r.b. 2(3/0) 75cm I-137 10140-55 DW8942 Unicryl 26mm 1/2c.r.b. 2(3/0) 75em' --138 10139-04 DW8942 Uni:ryl 26mm 1/2c.r.b. 2{3/0) 75cm -.~.-~---..~-~-139 10174-78 DW8942 Unicryl 26rnm 1/2c.r.h. 2(3/0) 75cm _ .._-----140 10267-53 DW8942 Unicryl 26mro 1/2c.r.b. 2(3/0) 75cm ----141 10140-54 DW8943 Unicryl 26mm 1/2c.r.b. 3(2/0) 75cm_. .---.--1112 10174-79 DW8943 Unicryl 26mm 1/2c.r.b. 3(2/0) 75cl1)

-_._-_.j--143 10267-57 DW2943 Unicryl 26mm 1/2e.r.b. 3(2/0) 75cm

144 10190-02 DW8943 Unicryl 26mi11 1/2c.r.b. 3(2/0) 75cm~145 10062-24 DW894359 Unicryl 26mrn Y2c.r.b. 3(2/0) 90cm ._-!

146 10319-04 DW8832 Unicryl 26mm curv.cutt. 2(3/0) 75cm

147 10040-07 DW8833 Unicryl 26mm curv.cutt. 3(2/0) 75cm .-._.._-----148 10363-02 DW8833 Unicryl 26mm curv.cutt. 3(2/0) 75cm -------149 10319-05 DW8833R Unicryl 26mrn eurv.rev.cutt. 3(2/0) 75cm. ---ISO 10171-05 5D8295 Unicryl 27mm 1/2c.r.b. 3(2/0) 75cm --_ ..151 10320-01 5E 206 Unicryl 30mm 1/2e r.b, 3(2/0) 90cm --------j152 10140-59 DW8952 Unicryl 30mm 1/2e.r.b. 2(3/0) 75cm -.----~.,--~--153 10137-05 DW3953 Unicryl 30mm 1/2c.r.b. 3(2/0) 75cm-

UNI®



154 10666-05 DW8953 Unicryl 30mm 1/2c.r.b. 3(2/0) 75cm





159 10262-02 DW8953 Unicryl30mm 1/2c.r.b. 3(2/0) 75cm


Unicryl 30mm 1/2c.r.b. 3(2/0) 75cm-----

161 10488-02 DW8953

162 10091-01 DW8953 Unicryl 30mm 1/2:::.r.b. 3(2/0) 7Scm --163 10112-01 DW8954 Unicryl 30mm 1/2c.r.b. 3.5(0) 75cm

164 10140-56 DW8954 Unicryl 30mm 1/2c.r.b. 3.5(0) 75cm

165 10140-56 DW8954 Unicryl 30mm 1/2c.r.b. 3.5(0) 75cm -166 10174-82 DW8954 Unicryl 30mm 1/2c.r.b. 3.5(0) 75cm .167 10174-83 DW8955 Unicryl 30mm 1/2c.r.b. 4(1) 75cm


169 10062-29 DW8993 Unicryl 35mm 1/2c.r.b. 3(2/0) 75cm =J170 10140-60 DW8993 Unicryl 3Smm 1/2c.r.b. 3(2/0) 75cm =J171 10171-07 DW8995 Unicryl 35mm 1/2c.r.b. 4(1) 75cm

172 10062-30 DW8563 Unicryl 35mfn curv.cutt. 3(2/0) 75cm

-~173 10205-03 5D8668 Unicryl 35mm curv.cutt. 3.5(0) 75cm

174 10303-01 5E 130 Unicryl 37mm 1/2c.r.b. 3(2/0) 75cm

175 10307-01 5E 130 Unicryl 37mm 1/2c.r.b. 3(2/0) 75cm I176 10509-01 SE 130 Unicryl 37mm 1/2c.r.b. 3(2/0) 75cm .;177 I 10633-29 5E 130 Unicryl 37mm 1/2c.r.b. 3(2/0) 75cm .----1178 10303-02 59892 Unicryl 37mm 1/2c.r.b. 3.5(0) 7Scm '---j179 10194-03 598925 Unicryl 37rnm 1/2c.r.b. 3.5(0) 90cm

180 10247-02 DW8513 Unicryl 40mrn 1/2c.r.b. 3(2/0) 75cm

181 10140-67 DW8513 Unicryl 40mm 1/2c.r.b. 3(2/0) 7Scm _. __ J

182 10172-17 DW8513 Unicryl 40mri1 1/2c.r.l:1. 3(2/0) 75cm

183 10564-08 DW8513 Unicryl 40mm 1/2c.r.b. 3(2/0) 75cm .-184 9755-58G DW8514 Unicryl 40mm l/2c.r.b. 3.5(0) 75cm_. .--185 9755-58J DW8514 Unicryl 40mrn 1/2c.r.b. 3.5(0) 75cm -------186 9755-58M DW8514 Unicryl 40mm 1/2c.r.b. 3.5(0) 75cm .-187 10370-62 DW8514 Unicryl 40mm 1/2c.i-.b. 3.5(0) 75cm ._--188 10370-62C DW8514 Unicryl 40mm 1/2c.r.b. 3.5(0) 75cm =-j189 10370-62B DW8514 Unicryl 40mm 1/2c.r.b. 3.5(0) 75cm --190 10139-09 DW8514 Unicryl 40mm 1/2c.r.b. 3.5(0) 75cm

·1191 10140-65 DW8514 Unicryl 40mm 1/2c.r.b. 3.5(0) 75cm ,---,192 10488-01 DW8514 Unicryl40mm 1/2c.r.b. 3.5(0) 75cm..- --193 10190-01A-JDW8514 Unicryl40mm 1/2cJ.b. 3.5(0) 7.5cm

194 10203-15 !DW8514 Unicryl40mm 1/2c.r.b. 3.5(0) 75cm -=J195 10633-02 DW851·l Unicryl40mm 1/2c.r.b. 3.5(0) 75cm ._---

UNI®


United Medical Industries Co. ltd.

196 10194-02 DW8514S Unicryl 40mm 1/2c.r.b. 3.5(0) 90cm

197 10666-03 DW8515 Unicryl40mm 1/2c.r.b. 4(1) 75cm

198 10062-33 DW8515 Unicryl40mm 1/2c.r.b. 4(1) 75cm --199 10140-66 DW8515 Unicryl40mm 1/2c.r.b. 4(1) 75cm

200 10172-18 DW8515 Unicryl 40mm 1/2c.r.b. 4(1) 75cm -----201 10500-33 DW8515 Unicryl 40mm 1/2c.r.b. 4(1) 75cm

202 10762-01 DW8515 Unicryl40mm 1/2c.r.b. 4(1) 75cm --203 10338-03 DW8515S Unicryl 40mm 1/2c.r.b. 4(1) 90cm

204 10194-06 DW8515S Unicryl 40mm 1/2c.r.b. 4(1) SOcm

205 10172-20 DW8516 Unicryl 40mm 1/2c.r.b. 5(2) 75cm --206 10174-61 DW8516 Unicryl40mm 1/2c.r.b. 5(2) 75cm


1208 10140-68 DW8514H Unicryl40mm 1/2c.r.b.hvy. 3.5(0) 75cm

209 10174-58 DW8514H Unicryl 40mm 1/2c.r.b.h'JY. 3.5(0) 75cm


211 10139-12 DW8515H Unicryl 40mm 1/2c.r.b.hvy. 4(1) 75crn

212 10172-19 DW8515H Unicryl 40mm 1/2c.r.b.hvy. 4(1) 75cm --213 10140-63 DW8524R Unicryl 40mm 1/2c.rev.cutt. 3.5(0) 75cm --214 10174-62 IDW8524R Unicryl 40ml1' 1/2c.rev.CL!tt. 3.5(0) 75cm

--.-~2Ei 10140-62 DW8525R Unicryl40mm 1/2c.rev.cutt. 4(1) 75cm

216 10174-63 DW8525R Unicryl 40m:TI 1/2c.rev.cutt. 4(1) 75cm ---217 10101-01 DW852SR Unicryl ·10rnm 1/2cxev.cutl. 4(1) 75cm-- .------1218 10140-64 DW8526R Unicryl 40mm l/2c.rev.cutt. 5(2) 75cm


220 1020S-01A 5D8189 Unicryl 40mm curv.cutt. 4(1) 75cm --------221 10363-01 5D8189 UnicryI40mmcurv.cutt. 4(1) 75cm ---222 10633-39 DW8855S7 Unicryl 45mm l/2c.r.b. 4(1) 75cm

223 10452-04 DW885657 Unicryl 45mm 1/2c.r.b. 5(2) 75cm --224 10399-01 DW8854 Unicryl 45mm 1/2c.r.b.hvy. 3.5(0) 75cm-- ----I

225 10452-01 DW8854 Unicryl45mm 1/2c.r.bJ~yy. 3.5(0) 75cm ---._--.J226 10376-02 DW3855 Unicryl 45rnm 1/2c.r.b.hvy. 4(1) 75cm -227 10589-01 DW8855 Unicryl 45rnm 1/2c.r.b.hvy. 4(1) 75cm--- --_._-228 10502-02 DW8856 Unicryl 45mrn 1/2c.r_b.hvy.5(2) 75cm --

! 229 10399-03 DW8856 Unicryl45mrn 1/2c.r.b.hvy.5(2) 75cm--

230 10267-64 DW8856 Unicryl 45mm 1/2c.r.h.hvy.5(2) 75cm --.-.----231 10102-01 DW8856 Unicryl45mm 1/2c.r.b.hvy.5(2) 75cm

232 10098-01 DT8536 Unicryl45mrn1/2ctapeLcut 5(2) 75cm 1_..=:J233 10062-37 DW8556 Unicryl 50mrn :tf2c.r.b. 5(2) 75c01

234 10423-27 DW8C55R Unicryl 50mm 1/2c.rev.cutt. 4(1) 75cm

Unicryl GOmm ~tr.c~tt. 2(3/0) 75cm ]-

235 10633-38 DW8S72 -------236 10138-01 DW8628D5 Unicryl6mm curv.spat.d/a.0.5(7/0) 45cm- -237 10423-29 DW8379D Unicryl8mm 1/4c.spat.d/a 0.7(6/0) 45cm ---~-----.

UNI®



238 10712-05 DW8502 Unicryl cut lengths 2(3/0) 1.5m

239 10308-06 DW8504 Unicryl cut lengths 3.5(0) 1.5m

240 10308-07 DW8505 Unicryl cut lengths 4(1) 1.5m


242 10338-01 DW8503 Unicryl cut lengths 3(2/0) 1.5 metres I243 10423-33 DW8503 Unicryl cut lengths 3(2/0) 1.5 metres --

Customer ActionPlease review your inventory fOI"products affected by this issue and perform the following actions:

1. Immediately identify and quarantine all unused, affected products in your inventory.

2. Return all unused, affected products in your inventory to Unimed. Our Representatives will assist you in the

return of affected product as necessary.

Please share this notificaticn with others in your organization as appropriate. If product within scope of this

recall has been forwarded to another facility, please notify the facility of the issue and assist with the

inconvenience that it may cause

Please be assured that patient safety and products quality remain our primary concern.

If you have any questions, please contact your Unimed Rep(esentatives.

Sincerely,

Nader Hamdan Assiri

UNI®



Urgent Field Safety NoticeUnicaprone Surgical Suture Recall

Date: 13/11/2016Unimed Reference: FSN02Dear NeMDR Team

This letter to inform you that we have identified that the Suture Breaking Strength in few incidents are

non compliant to European Pharmacopeia requirements


Serial Batch# Item Code Description

1 10370-112C DW13029V Unicaprone (violet) 22mm 1/2c.r.b. 2(3/0) 70cm

2 10370-111A DW13058V Unicaprone (violet) 30mm 1/2c.r.b. 3(2/0) 70cm

3 10370-32A DW13503V Unicaprone (violet) standard lengths 3(2/0) 1.5 metres

4 10370-32C DW13503V Unicaprone (violet) standard lengths 3(2/0) 1.5 metres .----5 10850-44 DW13013 Unicaprone 17mm curv.r.b. 1.5(4/0) 70cm

6 10860-02 DP13024 Unicaprone 19mm curv.P-type.rev.cutt. 2(3/0) 45crn

7 10846-13 DW13901RU Unicaprone 19mm curv.rev.cutt. J..5(4/0) 45cm

8 10370-107C DW13902RU Unicaprone 19mm curv.rev.cutt. 2(3/0) 45cm

9 10370-107D DW13902RU Unicaprone 19mm curv.rev.cutt. 2(3/0) 45cm

10 10846-14 DW13902RU Unicaprone 19mm curv.rev.cutt. 2(3/0) 45cm

11 10801-07 DW13902RS Unicaprone 19mm curv.rev.cutt. 2(3/0) 75cm

12 10850-45 DW13029 Unicaprone 22mm 1/2c.r.b. 2(3/0) 70cm


14 10370-106C DW13833RS Unicaprone 26mm curv.rev.cutt. 3(2/0) 70cm

15 10370-106D DW1J833RS Unicaprone 26mm curv.rev.cutt. 3(2/0) 70cm -16 10370-106F DW13833RS Unicaprone 26mm curv.rev.cutt. 3(2/0) 70cm

17 10712-03 DW13572U Unicaprone 60mm str.cutt. 2(3/0) 70cm

18 10370-33 DW13573 Unicaprone 60mm str.cutt. 3(2/0) 70cm

19 9755-113C DW13801VS Unicaprone (violet) _16mm 1/2c.r.b. 1.5(4/0) 75cm -..20 9755-112B DW13029V Unicaprone (violet) 22mm 1/2c.r.b. 2(3/0) 70cm

21 9755-110B DW13058V Unicaprone (violet) 30mm 1/2c.r.b. 3(2/0) 700n --122 9755-109C DW13084V Unicaprone (violet) 36mm 1/2c.r.b. 3.5(0) 70cm

23 9755-29C DW13503V Unicaprone (viol~_t) standard lengths 3(2/0) 1.5 metres --24 9755-108F DW13760RU Unicaprone 13mm curv.rev.cutt.l(5/0) 45cm

25 10370-109B DW13760RU Unicaprone 13mm curv.rev.cutt.Hfi/O] 45cm

26 10339-03 DP13008 Unicaprone 16rnm curv.P-type.rev.cutt. 1.5(4/0) 45cm --21 10423-05 DW13861RSU Unicaprone 16mm curv.rev.cutt. 1.5(4/0) 45cm --

UNI®



28 10267-28 DW13861RSU Unicaprone 16mm curv.rev.cutt. 1.5(4/0) 45cm

29 10240-15 DW13861RS7 Unicaprone 16mm curv.rev.cutt. 1.5(4/0) 75cm


31 10290-01 DP13023 Unicaprone 19mm curv.P-type.rev.cutt. 1.5(4/0) 45cm


33 9755-107B DW13901RU Unicaprone 19mm curv.rev.cutt. 1.5(4/0) 45cm

34 10062-02 DW13901RU Unicaprone 19mm curv.rev.cutt. 1.5(4/0) 45cm


36 9755-106B DW13902RU Unicaprone 19mm curv.rev.cutt. 2(3/0) 45cm --37 9755-106D DW13902RU Unicaprone 19mm curv.rev.cutt. 2(3/0) 45cm --38 10249-03 DW13902RS Unicaprone 19mm curv.rev.cutt. 2(3/0) 75cm

39 10028-32 DW13831S Unicaprone 26mm curv.cutt. 1.5(4/0) 75cm


41 10370-106A DW13833RS Unicaprone 26~m curv.rev.cutt. 3(2/0) 70cm

42 10608-03 DW13833R Unicaprone 26mm curv.rev.cutt. 3(2/0) 75cm ._____

43 10377-01 DW13058 Unicaprone 30mm 1/2c.r.b. 3(2/0) 70err, ==l44 10589-01 DT13079 Unicaprone 35mm Y2c.taper.cut. 3.5(0) 70cm

45 10062-04 DW13514S Unicaprone 40mm 1/2c.r.b. 3.5(0) 75cm ~

46 10334-01 DW13115 Unicaprone 40mm 1/2c.r.b.hvy.4(1) 70cm

47 10370-33A DW13573 Unicaplone 60mm str.cutt. 3(2/0) 70cm ______

Customer ActionPlease review your inventory for products affected by this issue and perform the following actions:



return cf affected product as necessary.

Please share this notification with others in your organization as appropriate. If product within scope of this




If you have any questions, please contact your Unimed Representatives.

Sincerely,

Nader Hamdan Assiri

UNI®



Urgent Field Safety NoticeUnicryl Quick Surgical Suture Recall

Date: 13/11/2016Unimed Reference: FSN03Dear NCMDR Team

This letter to inform you that we have identified that the Suture Breaking Strength in few incidents arenon compliant to European Pharmacopeia requirementsWe are initiating a voluntary recall for the following batches:


1 10936-01 DP12219R Unicrylquick12mmcurv.P-type.rev.cutt.0.7(6/0) 45cm

2 10370-102B DW12220R Unicryl quick 12mm curv.rev.cutt. 1(5/0) 45cm

3 10370-101A DW12801 Unicryl quick 16mm 1/2c.r.b. 1.5(4/0) l5cm

4 10850-42 DW12860 Unicryl quick 16mm curv.cutt. 1(5/0) 75cm

5 10706-02 DW12861 Unicryl quick 16mm curv.cutt. 1.5(4/0) 75cm --6 11023-07 DW12902 Unicryl quick 19mm curv.cutt. 2(3/0) 75cm

7 10943-20 DW12902R Unicryl quick 19mm curv.rev.cutt. 2(3/0) 75cm

8 10370-100C DW12922 Unicryl quick 20mm 1/2c.r.b. 2(3/0) 75cm

9 10370-100B DW12922 Unicrvl quick 20mm 1/2c.r.b. 2(3/0} 75cm 310 10370-100D DW12922 Unicryl quick 20mm 1/2c.r.b. 2(3/0) 75cm

11 10854-01 SD12000 Unicryl quick 22mm 1/2c.r.b. 2(3/0) 75cm

12 10846-23 DW12833 Unicryl quick 26mm curv.cutt. 3(2/0) 75cm _


14 10370-98C DW12833RU Unicryl quick 26mm curv.rev.cutt. 3(2/0) 75cm

15 10370-98D DW12833RU Unicryl quick 26mm curv.rev.cutt. 3(2/0) 75cm


17 10825-03 DW12953 Unicryl quick 30mm 1/2c.r.b. 3(2/0) 75cm --18 10929-01 DT12873US9 Unicryl quick 35mm 1/2c.taper.cut. 3(2/0) 90cm

19 10881-01 DT12874S9 Unicryl quick 35mm 1/2c.tapeLcut. 3.5(0) 90cm

20 10370-95C SD12030HS Unicryl quick 36mm 1/2c.r.b.hvy. 3(2/0) 90cm

21 11101-106 SD12030HS Unicryl quick 36mm 1/2c.r.b.hvy. 3(2/0) 90cm

22 10774-01 DW12513 Unicryl quick 40mm 1/2c.r.b. 3(2/0) 75cm --23 10370-94D SD17.008H Unicryl quick 50mm 1/2.c.r.b.hvy. 3(2/0) 75cm .-----24 10370-94C SD12008H Unicryl quick 5Cmm 1/2.c.r.b.hvy. 3(2/0) 75cm

25 11101-105 SD12008H Unicryl quick 50mm 1/2.c.r.b.hvy. 3(2/0) 75cm

26 9755-103A DW12801 Unicryl quick 16n;.m1/2c.r.b. 1.5(4/0) 75cm I

Product Name: UniCryl Quick

UNI®

Head Office P.O.Box51871Riyadh 11553Saudi ArabiaTel: +966 11 265 0665Fax: +966 11 265 [email protected]


27 10267-39 DW12861 Unicryl q~ick 16mm curv.cutt. 1.5(4/0) 75cm


29 10183-03 DW12901R Unicryl quick 19mm curv.rev.cutt. 1.5(4/0) 75cm




33 10172-04 DW12902R Unicrvl quick 19rnm curv.rev.cutt. 2(3/0) 75cm

34 9755-102B DW12922 Unicryl quick 20mm 1/2c.r.b. 2(3/0) 75cm

35 10191-04 DW12922 Unicryl quick 20mm 1/2c.r.b. 2(3/0) 75cm

36 10062-45 DW12832S Unicryl quick 26mm curv.cutt. 2(3/0) 45cm


38 10062-46 DW12833 Unicryl quick 26mm curv.cutt. 3(2/0) 75cm -_.-39 10139-03 DW12833 Unicryl quick 26mm curv.cutt. 3(2/0) 75cm

40 10062-47 DP12832RS7 Unicryl quick 26rnm curv.P-type.rev.cutt. 2(3/~) 75~m

41 10174-03 DP12832RS7 Unicry! quick 26mm curv.P-type.rev.cutt. 2(3/0) 75cm --42 10612-01 DP12832RS7 Unicryl quick 26mm curv.P-type.rev.cutt. 2(3/0) ?~cm

43 10502-03 DW12832RS Unicryl quick 26mm curv.rev.cutt. 2(3/0) 45cm ---

=:344 9755-1008 DW12833RU Unicryl quick 26m;:n curv.rev.cutt. 3(2/0) 75cl11

45 10370·98 DW12833RU Unicryl quick 26mm curv.rev.cutt. 3(2/0) 75cm

46 9755-101A DW12953 Unicryl 9.ulck 30mm I/2c.r.b. 3(2/0) 75cm

--- ~

1-.

, 47 10721-01 DT12873US9 Unicryl quick 3Smm 1/2c.taper.cut. 3(2/0) 90cm

48 10254-01 DT12874S9 Unicryl quick 35mm 1/2c.taper.cut. 3.5(0) 90cm I--l49 10370-96 SD12062H Unicryl quick 36mm 1/2c.r.b.hvy 2(3/0) 90cm I

- --50 10370-96A SD12062H Uni~ryl quick 3Gn~m 1/2c.r.b.hvy 2(3/0) 90cm-- _. --------51 9755-97A SD12030HS Unicryl quick 36mm 1/2c.r.b.hvy. 3(2/0) 90cm- ._------52 10370-95 SD12030HS Unicryl quick 36mm 1/2c.r.b.hvy. 3(2/0) 90cm -------- ..--53 10370-95A SD12030HS Unicryl quick 36mm 1/2c.r.b.hv'l. 3(2/0) 90cm -------,54 10370-95B SD12030HS Unicryl quick 36mm 1/2c.r.b.hvy. 3(2/0) gOcm

~

55 10700-27 ST12059 Unicryl quick 36mm 1/2c.taper.cut. 3(2/0) 90crn

56 10370-94 SD12008H Unicryl quic_~50mm 1/2.c.r.b.hvy. 3(2/0) 75cm

57 10608-01 DW12573 Unicryl quick 60mm str.cutt. 3(2/0) 75cm---~

-----~. .-"-.__.- -

Head Office P.O.Box51871

UNIM ~~a~~~il3,;~u:!A~~~~

Fax: +966 11 265 0569

United Medicallnc;l.ustries Co. Ltd. www. u n i m e d. com. 5 aCustomer Action [email protected] review your inventory for products affected by this issue and perform the following actions:









Sincerely,

Nader Hamdan Assiri

UNI®



Urgent Field Safety NoticeUniglactin Surgical Suture Recall

Date:13/11/2016Unimed Reference: FSN04Dear NCMDR Team




serial Batch# Item Code Description

1 10370-60C DWl1220RSU Uniglactin (ud) 12mm curv.rev.cutt. 1(5/0) 75cm

2 10760-01A DW11860U Uniglactin (ud) 16mm curv.cutt. 1(5/0) 75cm

3 11001-01A DW11832RS7U Uniglactin (ud) 26mm curv.rev.cutt. 2(3/0) 75cm

4 10370-89L DW11219S4 Uniglactin 12mm curv.cutt. 0.7(6/0) 45cm --5 10370-89J DW11219S4 Uniglactin 12mm curv.cutt. 0.7(6/0) 45cm

6 10370-89N DWl1219S4 Uniglactin 12mm curv.cutt. 0.7(6/0) 45cm

7 10370-89R DW11219S4 Uniglactin 12mm curv.cutt. 0.7(6/0) 45cm

8 10370-83D DWl1388S4 Uniglactin 13mm curv.r.b. 1.5(4/0) 45cm --9 10370-83E DWl1388S4 Uniglactin 13mm curv.r.b. 1.5(4/0) 45cm

10 10370-831 DWl1388S4 Uniglactin 13mm curv.r.b. 1.5(4/0) 45cm

11 10370-81H DWl1389 Uniglactin 13mm curv.r.b. 2(3/0) 45cm

12 10370-81F DWl1389 Uniglactin 13mm curv.r.b. 2(3/0) 45cm .-13 10775-01 DWl1398S Unlglactin 13mm str.cutt. 1.5(4/0) 75cm --14 10370-82F DW11862 Uniglactin 16mm curv.cutt. 2(3/0) 75cm

15 10370-82K DW11862 Uniglactin 16mm curv.cutt. 2(3/0) 75cm

16 10370-82J DW11862 Uniglactin 16mm curv.cutt. 2(3/0) 75cm j17 10370-86B DW11860 Uniglactin 16mm curv.cutt. 1(5/0) 75cm

18 10370-86D DW11860 Uniglactin 16mm curv.cutt. 1(5/0) 75cm

19 10370-86E DW11860 Uniglactin 16mm curv.cutt. 1(5/0) 75cm --20 11101-96 DW11860 Uniglactin 16mm curv.cutt. 1(5/0) 75cm --21 10370-84B DW11841S Uniglactin 16mm curv.r.b. 1.5(4/0) 75cm

22 10370-80B DW11922 Uniglactin 20mm 1/2c.r.b. 2(3/0) 15cm

23 10370-80A DW11922 Uniglactin 20mm 1/2c.r.b. 2(3/0) 75cm

24 10825-04 DW11922 Uniglactin 20mm 1/2c.r.b. 2(3/0) 75cm'----- -25 11101-89 SD11008 Uniglactin 25mm 1/2c.r.b. 2(3/0) 75cm --26 11101-89G SD11008 Uniglactin 25mm I/l-c.r.b. 2(3/0) 75cm --27 11101-89F SD11008 Uniglactin 25mm l/2c.r.b. 2(3/0) 75cm

'--- --

Product Name: Uniglactin

UNI®



28 11101-83 5011021 Uniglaetin 2smm 1/2e.r.b. 3(2/0) 7sem


30 11101-830 5011021 Uniglactin 25mm 1/2e.r.b. 3(2/0) 75em

31 11101-79 0T11823 Uniglaetin 25mm 1/2c.taper.eut. 3(2/0) 75em

32 10370-75B 0T11823H Uniglaetin 25mm 1/2e.taper.eut.hvy. 3(2/0) 75em

33 10370-75C 0T11823H Uniglaetin 25mm 1/2e.taper.eut.hvy. 3(2/0) 75em

34 10370-65C SOl1170H Uniglactin 25mm 5/8e.r.b.hvy. 3.5(0) 75em

35 10370-65E S011170H Uniglaetin 2smm s/8e.r.b.hvy. 3.5(0) 75em

36 10700-05 DW11941 Uniglaetin26mm 1/2e.r.b. 1.5(4/0) 75em

37 10949-01 OW11943 Uniglaetin 26mm 1/2e.r.b. 3(2/0) 7sem

38 11107-01 DW11943 Uniglaetin 26mm 1/2e.r.b. 3(2/0) 7sem

39 10700-02A OW11945 Uniglactin 26mm 1/2e.r.b. 4(1) 75em

40 11107-04 5011130 Uniglaetin 26mm 1/2e.r.b.1(s/0) 75em

41 10370-74A OW11943SA Uniglaetin 26mm(Blaek) 1/2e.r.b. 3(2/0) 70em

42 10961-02 OW11943SA Uniglaetin 26mm(Blaek) t/zc.r.b. 3(2/0) 70em --43 11101-84B OW11953 Uniglaetin 30mm 1/2er.b. 3(2/0) 7sem

44 11101-84 OW11953 Uniglaetin 30mm 1/2e.r.b. 3(2/0) 75em


46 10370-661 0\N11954 Uniglaetin 30mm 1/2e.r.b. 3.5(0) 7sem --47 10370-66H OW11954 Uniglactin 30mm 1/2e.Lb. 3.5(0) 75em

48 10310-66J DW11954 Uniglaetin 30mm 1/2e.r.b. 3.5(0) 75em

49 10J70-66N 0lN11954 Uniglaetin 30mm 1/2e.r.b. 3.5(0) 7sem

50 10370-66M OW11954 Uniglaetin 3001m l/2e.r.b. 3.5(0) 75em

~

51 10370-660 OW11954 Uniglactin 30mm 1/2e.r.b. 3.5(0) 75em

52 11101-66 OW1l954 Uniglaetin 30mm 1/2e.r.b. 3.5(0) 7sem

53 11101-G6E OW11954 Uniglaetin 30mm 1/2e.r.b. 3.5(0) 7sem

54 10370-69H OW11955 Unigiaetin 30mm 1/2e.r.b. 4(1) 75em

55 10370-69G OW11955 Uniglaetin 30mm 1/2e.r.b. 4(1) 75em

56 10370-69J DW11955 Uniglaetin 30mm 1/2e.r.b. 4(1) 7scm

57 10370-69L OW11955 ~niglaetin 30mm 1/2e.r.b. 4(1) 7sem- --58 10370-69M OW11955 Uniglaetin 30mm 1/2c.r.b. 4(1) 7sem

.-59 10370-69N DW11955 Uniglactin 30mm 1/2e.r.b. 4(1) 75em --60 10370-690 OW11955 Uniglaetir. 30mm 1/2e.r.b. 4(1) 7sem -_ ..-61 1.0370-69P OW11955 Uniglaetin 30mm l/2c.r.b. 4(1) 7sem -----62 11101-70A OW11955 Uniglactin 30mm 1/2e.r.b. 4(1) 7sem --63 10370-77A DW119530 Uniglaetin 30mm 1/2c.r.b.d/a 3(2/0) 75em--64 11101-81A OW119530 Uniglaetin 30mm 1/2e.r.b.d/a 3(2/0) 75em

65 10370-76E S011085A Unigiaetin 30mm curv.r.b, 3(2/0) 7sem

66 10370-76F S011085A Uniglaetin :;'Omm eurv.r.b. 3(2/0) 7sem

67 11101-65A SOl1171 Uniglactin 30mm eurv.r.b.3.5(O) 75em

68 11101-65 5011171 Uniglaetin 30mm eurv.r.b.3.s(0) 75em --69 11094-01 OW11993 uniglactin 3smm 1/2e.r.b. 3(2/0) 7sem--- ---

UNI®



70 11101-71 DTl1565 Uniglactin 35mm 1/2c.taper.cut.hvy. 4(1) 75cm

71 11101-71D DTl1565 Uniglactin 35mm 1/2c.taper.cut.hvy. 4(1) 75cm

72 10370-61B 5D111565 Uniglactin 36mm j.r.b. 3.5(0) 70cm

73 10370-61C 5D111565 Uniglactin 36mm j.r.b, 3.5(0) 70cm

74 10370-67V DW11514 Uniglactin 40mm 1/2c.r.b. 3.5(0) 75cm_. ..-75 10370-67Y DW11514 Uniglactin 40mm 1/2c.r.b. 3.5(0) 75cm

76 10370-67AH DW11514 Uniglactin 40mm 1/2c.r.b. 3.5(0) 75cm

77 10370-67AI DW11514 Uniglactin 40mm 1/2c.r.b. 3.5(0) 75cm

78 10370-67AF DW11514 Uniglactin 40rnm 1/2c.r.b. 3.5(0) 75cm

79 10370-67AE DW11514 Uniglactin 40mm 1/2c.r.b. 3.5(0) 75cm

80 10370-67AJ DW11514 Uniglactin 40mm 1/2c.r.b. 3.5(0) 75cm

81 10370-67AD DW11514 Uniglactin 40mm 1/2c.r.b. 3.5(0) 75cm- -82 10370-67AN DW11514 Uniglactin 40mm 1/2c.r.b. 3.5(0) 75cm --83 10370-67AK DW11514 Uniglactin 40mrn 1/2c.r.b. 3.5(0) 75cm

84 11101-67A DW11514 Uniglactin 40mm 1/2c.r.b. 3.5(0) 75cm ----85 11101-67J DW11514 Uniglactin 40mm 1/2c.r.b. 3.5(0) 75cm

86 11101-721\,1 DWl1515 Uniglactin 40mm 1/2c.r.b. 4(1) 75cm

87 11101-72A DWl1515 Uniglactin 40mm 1/2c.r.b. 4(1) 75cm --88 10834-01 DW115155 Uniglactin 40mm 1/2c.r.b. 4(1) 90cm_. -----89 11177-01A DW115155 Uniglactin 40mm 1/2c.r.b. 4(1) 90cm

90 10700-15 DW11516 Uniglactm 40mm 1/2c.r.b. 5(2) 75cm

91 10370-78D 5Dl1175 Uniglactin 40mm curv.r.b. 3(2/0) 75cm

92 10370-78H 5Dl1175 Uniglactin 40mm curv.r.b. 3(2/0) 75cm

I--93 10370-78F SDl1175 Uniglactin 40mm curv.r.b. 3(2/0) 75cm

94 11101-68 DW118555 Uniglactin 45mm 1/2c.r.b. 4(1) 75cm

95 11101-68B DW118555 Uniglactin 45mm 1/2c.r.b. 4(1) 75cm --96 10913-01 DW11855B5 Uniglactin 45mm 1/2c.r.b.blunt. 4(1) 90cm

97 10370-71N DTl1536 Uniglactin 45mm 1/2c.taper.cut. 5(2) 75crn --98 10370-71P DT11536 Uniglactin 45mm 1,/2c.taper.cut. 5(2) 75cm I--99 10370-71Q DTl1536 Uniglactin 45mm 1/2c.taper.cut. 5(2) 75cm --100 10370..71V DTl1536 Uniglactin 45mm 1/2c.taper.cut. 5(2) 75cm --101 10370-71U DTl1536 Unigiactin 45mm 1/2c.taper.cut. 5(2) 75cm

102 10370-71AA DTl1536 Uniglactin 45mm 1/2c.taper.cut. 5(2) 75cm

103 10370-71Y DTl1536 Uniglactin 45mm 1/2c.taper.cut. 5(2) 75cm

104 10370-71AB DT11536 Unlglactin 45mm 1/2c.taper.cut. 5(2) 75cm

105 10370-71X DTl1536 Uniglactin 45mm 1/2c.taper.cut. 5(2) 75cm --106 10370-71AD DTl1536 Uniglactin 45mm 1/2c.taper.cut. 5(2) 75cm

1-. --107 10370-71AC DTl1536 Uniglactin 45mm 1/2c.taper.cut. 5(2) 75cm

108 10370-71Z DTl1536 Uniglactin 45mm 1/2c.taper.cut. 5(2) 75cm --109 10370-71AI DTl1536 Uniglactin 45mm 1/2c.taper.cut. 5(2) 75cm --110 10370-71AG DTl1536 Uniglactin 45mm 1/2c.taper.cut. 5(2) 75cm

111 10370-71AH DTl1536 Unlglactin 45mm 1/2c.taper.cut. 5(2) 75cm ____J

UNI®



112 10370-71AE DTl1536 Uniglactin 45mm :"/2c.taper.cut. 5(2) 75cm

113 11101-74E DTl1536 Uniglactin 45mm 1/2c.taper.cut. 5(2) 75cm

114 11101-74A DTl1536 Uniglactin 45mm 1/2c.taper.cut. 5(2) 75cm --115 11101-74C DTllS36 Uniglactin 45mm 1/2c.taper.cut. 5(2) 75cm

116 11101-74B DTl1536 Uniglactin 45mm 1/2c.taper.cut. 5(2) 75cm

117 10986-01 DTl1536H Uniglactin 45mm 1/2c.taper.cut.hvy. 5(2) 75cm

118 10700-18 5D11155 Uniglactin 48mm 1/2c.r.b. 5(2) 75cm

119 10370-631 DW11554 Uniglactin 50mm 1/2c.r.b. 3.5(0) 75cm

120 10370-63H DW11554 Uniglactin 50mm 1/2c.r.b. 3.5(0) 75cm

121 10370-63J DW11554 Uniglactin 50mm 1/2c.r.b. 3.5(0) 75cm

122 10370-63K DW11554 Uniglactin SOmm 1/2c.r.b. 3.5(0) 75cm

123 11101-62A DW11554 Uniglactin 50mm 1/2c.r.b. 3.5(0) 75cm

124 10370-59C DW11555 Uniglactin 50mm 1/2c.r.b. 4(1) 75cm

125 10370-59D DW11555 Uniglactin 50mm 1/2c.r.b. 4(1) 75cm

126 10370-59F DW11555 Uniglactin 50mm 1/2c.r.b. 4(1) 75cm

127 10370-59H DW11555 Uniglactin 50mm 1/2c.r.b. 4(1) 75cm

128 11101-58B DW11555 Uniglactin 50mm 1/2c.r.b. 4(1) 75cm ---129 10370-68B 5D11172BH Uniglac~in 5.9mm 1/2c.r.b.blnt.hvy.4(1) 75cm ..-130 10370-68D 5D11172BH Unlglactin 50mm 1/2c.r.b.blnt.hvy.4(1) /5cm -----131 10370-791 DW11573 Uniglactin 60mm str.cutt. 3(2/0) 75cm

!- 132 10370-79H DW11573 Uniglactin 60mm str.cutt. 3(2/0) 75cm

133 10370-79l DW11573 Uniglactin 60mm str.cutt. 3(2/0) 75cm ------134 10370-790 DW11573 Uniglactin 60mm str.cutt. 3(2jO) 75cm~.135 10370-79Q DW11573 Uniglactin 60mm str.cutt. 3(2/0) 75cm --136 10370-79P D'N11573 Uniglactin 60mm str.cutt. 3(2/0) 75cm -'--J137 10370-79R DW11573 Uniglactin 60mm str.cutt. 3(2/0) 75cm -_.-138 11101-85 DW11573 Uniglactin 60mm str.cutt. 3(2/0) 75cm I-----139 10370-72B 5D11174 Uniglactin 65mm curv.r.b. 3(2/0) 75cm --140 10370-64C 5D11169 Uniglactin 65mm curv.r.b. 3.5(0) 75cm -------141 10370-640 5011169 Uniglactin 65mm rurv.r.b. 3.5(0) 75cm

142 11101-63 5D11169 Uniglactin 65mm curv.r.b. 3.5(0) 7Scm

143 10370-93F 50110535 Uniglactin 8mm 1/2c.rev.cutt. d/a O.4(B/O) 45cm..-

144 10370-91F 5D11121RO Uniglactin Brr.rn 1/2c.rev.cutt.d/a 0.5(7/0) 45cm- -----.=,------ --145 10370-92F DW116675 Uniglactin Bmm curv.r.b. 0.4(8/0) 30cm ._--146 10370-105A DW11462 Uniglactin cut lengths 2(3/0) 10x50cm

147 10370-105B DW11462 Uniglactin cut lengths 2(3/0) 10x50cm --148 11101-116 OW11462 Uniglactin cut lengths 2(3/0) 10xSOcm -.-149 10370-104B DW11463 Uniglactin cut lengths 3(2/0) 10x50cm ----150 11101-115A DW11463 Uniglactin cut lengths 3(2/0) 10x50cm -----151 10370-73C DW11503 Uniglactin cut lengths 3(2/0) 1.~ metres ------152 10370-73E DW11503 Uniglactin cut length.s 3(2/0) 1.5 metres ------153 11101-76 OW11503 IUniglactin cut lengths 3(2/0) 1.5 metresL..--. -------

UNI®

Head Office P.O.Box 51871

Riyadh 11553 Saudi Arabia

Tel: +966 11 265 0665

Fax: +966 11 265 0569www.unimed.com.sa

[email protected] Medical Industries Co. Ltd.

--154 10918-01 DW11503 Uniglactin cut lengths 3(2/0) 1.5 metres

155 10370-103B DW11464 Uniglactin cut lengths 3.5(0) 10x50cm

156 10760-01 OW11860U Uniglactin (ud) 16mm curv.cutt. 1(5/0) 75cm

157 10358-01 OP119025U Uniglactin (ud) 19mm curv.P-type.cutt. 2(3/0) 45cm

158 10578-01 5D1109154UE Uniglactin (ud) 20mm curv.extra.cutt. 2(3/0) 45cm

159 9755-93N 501100154 Uniglactin 13mm 1/2c.r.b. 0.7(6/0) 45cm

160 9755-93Q 501100154 Uniglactin 13mrr. 1/2c.r.b. 0.7(6/0) 45cm

161 9755-89F OW1138754 Uniglactin 13mm curv.r.b. 1(5/0) 45cm

162 9755-89E OW1138754 Uniglactin 13mm curv.r.b. 1(5/0) 45cm -163 9755-89G OW1138754 Uniglactin 13mm curv.r.b. 1(5/0) 45cm --164 9755-89J OW1138754 Uniglactin 13mm curv.r.b. 1(5/0) 45cm -

~-165 9755-85E OW1138854 Uniglactin 13mm curv.r.b. 1.5(4/0) 45cm

166 9755-85H DW1138854 Uniglactin 13mm curv.r.b. 1.5(4/0) 45cm --167 9755-82H OW11389 Uniglactin 13mm curv.r.b. 2(3/0) 45cm

168 9755-82G DW11389 Uniglactin 13mm curv.r.b. 2(3/0) 45cm --169 10555-01 OW11800 Uniglactin 16mm 1/2c.r.b. 1 (5/0) 75cm -----170 9755-83F OW11862 Unlglactln 16mm curv.cutt. 2(3/0) 75cm

171 9755-83L OW11862 Uniglactin 16mm curv.cutt. 2(3/0) 75cm

172 97S5-90G OW11860 Uniglactin 16mm curv.cutt. 1(5/0) 75cm ---_.-173 9755-87J OW11861 Uniglactin 16mm curv.cutt. 1.5(4/0) 75cm --174 9755-87i OW11861 Uniglactin 15mm curv.cutt. 1.5(4/0) 75cm ---175 9755-87L OW11861 Uniglactin 16mm curv.cutt. 1.5(4/0) 75cm

-~

876 9755-84K 5011008 Uniglactin 7.5mm 1/2c.r.b. 2(3/0) 75cm -----177 9755-84G 5011008 Uniglactin 25mm 1/2c.r.b. 2(3/0) 75cm

- 178--

9755-84N 5011008 Uniglactin 25mm 1/2c.r.b. 2(3/0) 75cm-~ 179 9755-840 5011008 ~~iglactin 25mm l/Lc.r.b. 2(3/0) 75cm

180 9755-78Z 5011021 Uniglactin 25mm 1/2c.r.b. 3(2/0) 75cm

181 9755-780 5011021 Uniglactin 25mm 1/2c.r.b. 3(2/0) 75cm J182 9755-78X 5011021 Uniglactin 25mm l/2c.r.b. 3(2/0) 75cm --183 9755-78Y 5D11021 Uniglactin 25mm J/2c.r.b. 3(2/0) 75cm-- --184 9755-78Q 5011021 Uniglactin 25mm 1/2c.r.b. 3(2/0) 75cm --185 9755-78W 5011021 Uniglactin 25mm 1/2c.r.b. 3(2/0) 75cm

186 10431-01 5011021 Uniglactin 25rnm 1/2c.r.b. 3(2/0) 75cm

187 9755-74E 0T11823H Uniglactin 25mm 1/2c.taper.cut.hvy. 3(2/0) 75cm

188 9755-740 0T11823H Uniglactin 25mm 1/2c.taper.cut.hvy. 3(2/0) 75cm


~190 9755-79F OW11953 Uniglactin 30mm 1/2c.r.b. 3(2/0) 75cm

191 10390-04 DW11953 Uniglactin 30mm l/~c.r.b. 3(2/0) 75cm

192 9755-63K DW11954 'Uniglactin 30m~ 1/2c.r.b. 3.5(0) 75cm --193 9755-63J OW11954 Uniglactin 30mm 1/2c.r.b. 3.5(0) 75cm

194 10370-66A OW11954 Uniglactin 30mm 1/2c.r.b. 3.5(0) 75cm--

195 9755-67L OW11955 Uniglactin 30mm 1/2c.r.b. 4(1) 75cm I --

UNI®



196 9755-67K DW11955 Uniglaetin 30mm 1/2e.r.b. 4(1) 75em

197 9755-67M DW11955 Uniglaetin 30mm 1/2e.r.b. 4(1) 75em

198 9755-670 DW11955 Uniglaetin 30mm 1/2e.r.b. 4(1) 75em

199 10370-69C DW11955 Uniglaetin 30mm 1/2e.r.b. 4(1) 75em --200 10370-69D DW11955 Uniglaetin 30mm 1/2e.r.b. 4(1) 75em

201 10370-69A DW11955 Uniglactin 30mm 1/2e.r.b. 4(1) 75em

202 9755-76D DW11953D Uniglaetin 30mm 1/2e.r.b.d/a 3(2/0) 75em

203 9755-75B 5D11085A Uniglaetin 30mm eurv.r.b. 3(2/0) 75em --204 9755-75E 5D11085A Uniglaetin 30mm eurv.r.b. 3(2/0) 75em

205 10370-76A 5D11085A Uniglaetin 30mm curv.r.b. 3(2/0) 75em

206 9755-62B 5Dl1171 Uniglaetin 30mm eurv.r.b.3.5(0) 75em

207 9755-62C 5Dl1171 Uniglaetin 30l11m curv.r.b.3.5(0) 75el11

208 9755-68J DT11565 Uniglaetin 35mm 1/2e.taper.eut.hvy. 4(1) 75em 1209 9755-68K DT11565 Uniglaetin 35mm 1/2e.taper.eut.hvy. 4(1) 75em --210 9755-681\1 DT11565 Uniglactin 35mm 1/2c.taper.eut.hvy. 4(1) 75em -211 10370 ..61A 5Dl11565 Uniglactin 36mm j.r.b. 3.5(0) 70em

212 9755-64M DW11514 Uniglaetin 40mm J./2e.r.b. 3.5(0) 75em-213 9755-6L1T DW11514 Uniglaetin 40mm 1/2e.r.b. 3.5(0) 75em ---214 9755-611R DW11514 Uniglaetin 40mm l/Le.r.b. 3.5(0) 75em- -- - --215 9755-541\G DW11514 Uniglaetin 40ml11 1/2e.r.b. 3.5(0) 75em

216 9755-64A,£o, DW11514 Uniglactin 40mm 1/2c.r.b. 3.5(0) 75em

~217 9755-647 DW11514 Uniglactin 40mm 1/2c.r.b. 3.5(0) 75el11

218 10370-67C DW11514 Uniglaclin 40mm 1/2e.r.b. 3.5(0) 75el11-t--. .--~-

219 10370-67G DW11514 Uniglactin 40ml11 1/2e.r.b. 3.5(0) 75el11 ---220 10370-67F DW11514 Uniglaetin 40mm 1/2e.r.b. 3.5(0) 75cm

221 103l0-67H DW11514 Uniglaetin 40mm 1/2e.r.b. 3.5(0) 75em --222 10370-67D DW11514 Uniglaetin 40l11m 1/2e.r.b. 3.5(0) 75em

223 9755-695 DW11515 Uniglaetin 40mm 1/2e.r.b. 4(1) 75em--224 9755··69W D\V11515 Unigl~etin 40mm 1/2e.r.b. 4(1) 75em

--. ---225 9755-69V DW11515 Uniglactin 40mm 1/2c.r.b. 4(1) 75cl11

-226 9755·G9T DW11515 Uniglactin 40mm 1/2c.r.b. 4(1) 75cm

227 9755-69X DW11515 Uniglactin 40mm 1/2c.r.b. 4(1) 75cm-228 9755-69Q DW11515 Uniglactin 40mm 1/2c.r.b. 4(1) 75cm -229 9755-69U DW11515 Uniglactin 40l11m 1/2c.r.b. 4(1) 75cl11

230 9755-69AG DW11515 Uniglactin 40mrn J./2c.r.b. 4(1) 75cm -----231 10305-02 DW11515 Uniglactin 40mm 1/2c.r.b. 4(1) 75cm

232 10390-01B DW11515 Uniglactin 40rnm 1/2c.r.b. 4(1) 75cm

233 10357-06 DW115155 Uniglaetin 40mm 1/2c.r.b. 4(1) 90cm

234 9755-77F 5Dl1175 Unigiactin 40mm curv.r.b. 3(2/0) 75::m ----235 9755-65H DW118555 Uniglac:tin 45mm 1/2c.r.b. 4(1) 75cm

236 9755-65L DW118555 Uniglactin 45mm 1/2c.r.b. 4(1) '15cm --237 9755-71i DT11536 Uniglactin 45mm 1/2c.taper.cut. 5(2) 75cm _J-

UNI®



238 9755-71H DT11536 Uniglaetin 45mm 1/2e.taper.eut. 5(2) 75em

239 9755-71M DT11536 Uniglaetin 45mm 1/2e.taper.eut. 5(2) 75em

240 9755-71N DT11536 Uniglaetin 45mm 1/2e.taper.eut. 5(2) 75em-241 9755-71U DT11536 Uniglaetin 45mm 1/2e.taper.eut. 5(2) 75em

242 9755-715 DT11536 Uniglaetin 45mm 1/2e.taper.eut. 5(2) 75em

243 9755-71K DT11536 Uniglaetin 45mm 1/2e.taper.cut. 5(2) 75em

244 9755-71W DT11536 Uniglaetin 45mll1 1/2c.taper.eut. 5(2) 75em

245 9755-71V DT11536 Uniglaetin 45mm 1/2e.taper.eut. 5(2) 75em

246 10370-71A DT11536 Uniglaetin 45mm 1/2e.taper.eut. 5(2) 75em

247 10370-71i DT11536 Uniglaetin 45mm 1/2e.taper.eut. 5(2) 75em

248 10370-71H DT11536 Uniglaetin 45mm 1/2e.taper.eut. 5(2) 75em -249 10370-71G DT11536 Uniglaetin 45mm 1/2e.taper.eut. 5(2) 75em-250 10370-71F DT11536 Uniglaetin 45mm 1/2e.taper.eut. 5(2) 75em


252 10305-01 DT11536 Uniglaetin 451l1m 1/2e.taper.eut. 5(2) 75em

253 10700-17 5D11075 Uniglaetin 48mm 1/2e.r.b. 4(1) 75em I -254 9755-59G DW11554 Uniglaetin 50mm 1/2e.r.b. 3.5(0) 75em ---255 9755-59i DW11554 Uniglaetin 50mm 1/2e.r.b. 3.5(0) 75em

--=J256 10370-63A DW11554 Uniglactin 50mm 1/2e.r.b. 3.5(0) 75em

257 10370-63 D'N11554 Uniglactin SOmm 1/2e.r.b. 3.5(0) 75em '---1-Uniglactin 50mm 1/2e.~.b. 4(1) 75em I258 10370-59 DW11555

259 10633-34 DW1155659 Uniglaetin 50mm 1/2e.r.b. 5(2) 90ern I -I260 9755-80i DW11573 Uniglaetin 60mm str.cutt. 3(2/0) 75em

261 9755-80J DW11573 Uniglaetin 60mm str.eutt. 3(2/0) 75em

262 9755-80K DW11573 Uniglaetin 60mm str.cutt. 3(2/0) 75em --263 975S-80U DW11573 Uniglaetin 60mrn str.eutt. 3(2/0) 75em

264 9755-805 DW11573 Uniglaetin 60mm str.eutt. 3(2/0) 75em-265 10370-79 DW11573 Uniglaetin 60mm str.eutt. 3(2/0) 75em- --266 10370-79E DW11573 Uniglaetin 60mm str.eutt. 3(2/0) 75em

..-267 10370-72A 5D11174 Uniglaetin 651l1m curv.r.b. 3(2/0) 75em -----268 10506-02 DW1l627D Uniglaetin 6mm eurv.spat.d/a 0.4(8/0) 30em --269 9755-96P SDll0535 Uniglactin Smrn 1/2e.rev.eutt. d/a 0.4(8/0) 45c:m ._---270 9755-94H 5DUI21RD Uniglactin Brnrn 1/2e.rev.eutt.d/a 0.5(7/0) 45cI11

271 9755-88G DW11380D Uniglaetin 81l1m 1/4e.spat.d/a 1(5/0) 45em ~=~Jf----- --272 9755-88N DWI13800 Uniglactln 8mm 1/4e.spat.d/a 1(5/0) 45em

273 10375-02 DW11379D5 Uniglaetin 8mm 1/4c.spat.d/a. 0.7(6/0) 20em

274 9755-95E OW116675 Uniglaetin 8mm eurv.r.b. 0.4(8/0) 30em

27S 9755-95F OW116675 Uniglaetin 8mm eurv.r.b. 0.4(8/0) 30em

276 9755-95L OW116675 Uniglaetin 8mm curv.r.b. 0.4(8/0) 30em1---

277 975S-91E DW11369 Uniglaetin Bmm curv.r.b. 0.7(6/0) 30em --l278 10370-73 DW11503 Uniglaetin cut lengths 3(2/0) 1.5 metres ]279 10370-103 DW11464 Uniglaetin cut lengths 3.5(0) 10x50em

UNl.Head Office P.O.Box51871Riyadh 11553Saudi ArabiaTel: +966 11 265 0665Fax: +966 11 265 [email protected]



1. Immediately identify and quarantine all unused. affected products in your inventory.

2. Return all unused. affected products in your inventory to Unimed. Our Representatives will assist you in the







Sincerely,

Nader Hamdan Assir!

UNI®


Urgent Field Safety NoticeUnicryl M Surgical Suture Recall







1 10370·38B OW1080057 Unicryl M 1Gmm 1/2c.Lb. 1(5/0) 70cm

2 10971·01 DW1080057 Unicryl M 16mrn 1/2e.Lb. 1(5/0j 7aem

3 10370-370 DW10801 Unieryl M 16mm 1/2e.Lb. 1.5(4/0) lOem

4 10925-01 . OW10861 Unieryl M 16mm curv.cutt. 1.5(4/0) 70em

5 10370-49B 5010040 Unieryl M 2Smm 1/2e.r.b. 1(5/0) 75em- -6 10370-49C 1,)010040 Unieryl M 2Smm 1/2e.r.b. 1(5/0) 7Sem

r--' -7 10370-48B 501003457 Unieryl M 25mrn 1/2e.Lb. 1.5(4/0) 75em

8 10370-46 SD10036 Unicryl rv~25mm 1/2r..r.b. 2(3/0) 75em-'

9 10370-46A 5010036 Unicryl M 25mm J/2t.r.b. 2(3/0) 75em

10 10370-46H 5010036 Unicrvl M 25m!:!~~c..:~_.b. 2{3/0) 75cmf------11 10370-47A DW1.09525 Unicryl M 30m;-n 1/2e.r.b.}(3/0) 7Scm_.12 11101-44A OW109525 Unicryl M 30mm l/2e.r.b. 2(3/0) 75cm

13 1082Y-01 OW10953 Unicryl M 30m~_y2c.r.b. 3(2/0) 70cm

~----

14 10370-44C OW109535 Unicryl IVI 30mm 1/2e.r.b. 3(2/0) 75cm

15 10370-440 OWI09535 Unieryl r.ll 30mm 1/2e.r.b. 3(2/0) 75cmi

16 11214-01 OW10954 Unieryl M 30mm 1/2e.Lb. 3.5(0) 70em

17 11169-01 DW10954 Unieryl M 30mm 1/2e.Lb. 3.5(0) 70cm

18 10370-410 5D10149 . Unicryl M 360101 1/2e.Lb. 3.5(0) 90cm---19 10370-41E SD10149 Unieryl M 36mm 1/2e.r.b. 3.5(0) 90em .---20 10846-07 OW10514 UnicrylM 40ml1" l/2er.b. 3.5(0) 70cm --21 11044-03 OWI0515L51 Unicryl M 40mm 1/lc.r.b. 4(1) 1.501 loop

22 10839-02 DW10515 Unicryl M 40m;" 1/2e.r.b. 4(l) 90cm I23 11076-01 DT1041759 Unieryl M 40mm 1/Le.tapeLeutA(l) 90em

24 10370-070 DWIOO64L5 UnicrylM 50mm V2c.r.b. 3.5(0) 15m loop

25 10370-07E DW10064L5 Unicrvl M 50mm 1/2e.Lb. 3.5(G) l.5m loop

26 9755-35,'\ OW1080057 Unicryl M 16mm 1/2e.r.b. 1(5/0) 70cm_. --27 9755-46D 5010040 Unieryl M 25mm 1/2e.r.b. 1(5/0) 75cm

28 10370-49 5010040 Unicryl M 25mm l/2e.r.b. Wi/OJ 75cm-------., ,29 10370-4?.-l5DIO~~0 UniC(.~ 25r:!:~1/2e.r.b. 1(5/0) 75cm

UNI®



30 9755-45A 5D1003457 Unicryl M 25mm 1/2c.r.b. 1.5(4/0) 75cm

31 9755-45B 5D1003457 Unicryl M 25mm 1/2c:!.b. 1.5(4/0) 7Scm

32 9755-43B 5D10036 Unicryl M 25mm 1/2c.r.b. 2(3/0) 75cm

33 9755-43C 5D10036 Unicryl M 25mm 1/2c.r.b. 2(3/0) 75cm

34 10467-01 5D10010 Unicryl M 25mrn 1/2c.r.b. 3(2/0) 70cm

35 10657-03 DW109435 Unicryl M 26mm 1/2c.r.b. 3(2/0) 75cm

36 10370-45 DW1094359A Unicryl M 26mm(Black) 1/2c.r.b. 3(2/0) 90cm

37 9755-44C DW109525 Unicryl M 30mm 1/2c.r.b. 2(3/0) 75cm_.38 10306-04 DW10953 Unicryl M 30mm 1/2c.r.b. 3(2/0) 70cm

39 975S-41C D'N109535 Unicryl M 30rnm 1/2c.r.b. 3(2/0) 75cm

40 10370-44 DW109535 Unicryl M 30mm l/Lc.r.b. 3(2/0) 75cm ,41 10370-44A DW109535 Unicryl M 30mm 1/2c.r.b. 3(2/0) 75cm

42 9755-38C 5D10149 Unicryl M 36mm 1/2c.r.b. 3.5(0) 90cm

43 10370-41A 5D10149 Unicryl M 36mm 1/2c.r.b. 3.5(0) 90cm-- --44 9755-408 5D10151 Unicryl M 36mm l/2c.r.b. 4(1) 90cm

45 9755-40C 5D10151 Unicryl M 36mm 1/2c.r.b. 4(1) 90cm-46 10370-43 5D10151 Unicryl M 36mm 1/2c.r.b. 4(1) 90cm---47 10370-43A 5D10151 Unicryl M 36mm 1/2c.r.b. 4(1) 90cm-48 10284-05 DW10515 Unicryl M 40mm 1/2c.r.b. 4(1) 90crn --I

t

49 10685-04 DWI051S ~~icryl M~Ornrn 1/2c.r.o. 4(1) 90cm C--_._--50 10486-01 DW10514LHS Unicrvl M 40mm 1/2u.b.hvy. 3.5(0)1.5m loop j51 10562-01 DTlO41759 Unicryl M 40mm 1/2c.taper.cut.4(1) 9Ccm



2. Return all unused, affected products in your inventory to Unimed. Our Representatives wil! assist you in the

return of arfe•.led product ~.i necessary.

Please share this notification with others in ycur organization as appropriate. If product within scope (If this




If you have anv questions, please contact your Unimed Reoresentatives.

UNI®



Urgent Field Saftey NoticeUnicryl Surgical Suture

Date: 13/1112016Unimed Reference: FSN01Dear NCMDR TeamThis letter to inform you that we have identified that the Suture Breaking Strength in few incidents are

non compliant to European Pharmacopeia requirements.


Serial Bateh# Item Code Oeseription

1 10777-06 OW8902U Unieryl (ud) 19mm eurv.eutt. 2(3/0) 75em



4 10705-16 OW8832R5U7 Unieryl (ud) 26mm eurv.rev.eutt. 2(3/0) 75em

5 11026-28 OW8833R57U Unieryl (ud) 26mm eurv.rev.eutt. 3(2/0) 75em --6 11130-02 OW8833RS7U Unieryl (ud) 26mm eurv.rev.eutt. 3(2/0) 75em--7 10705-17 OW8833R57U Unieryl (ud) 26mm eurv.rev.eutt. 3(2/0) 75em --8 10831-01 OW8572U Unieryl (ud) 60mm str.cutt. 2(3/0) 75em

9 11043-01 OW8572U Unieryl (ud) 60mm str.eutt. 2(3/0) 75em

10 11024-01 OW8759R Unieryl13mm eurv.rev.eutt. 0.7(6/0) 45em

11 11118-16 508214 Unieryl18mm eurv.eutt 1(5/0)75em --12 10754-01 OW8900R5 Unieryl19mm eurv.rev.eutt. 1(5/0) 45em

13 11090-37 OW8921 Unieryl 20mm 1/2e.r.b. 1.5(4/0) 75em

14 10850-49 OW8921 Unieryl 20mm 1/2e.r.b. 1.5(4/0) 75em---

15 10850-33 OW8921 Unieryl 20mm 1/2e.r.b. 1.5(4/0) 75cm -16 10850-49 OW8921 Unieryl 20mm 1/2e.r.b. 1.5(4/0) 75em --17 10841-23 5E 540 Unieryl 22mm 1/2e.r.b. 1.5(4/0) 75em --18 10878-01 59890 Unieryl 22mm 1/2e.r.b. 3(2/0) 75em

19 10841-18 OW89375 Unieryl 24mm eurv.eutt. 2(3/0) 75em

20 10841-14 OW8938 Unieryl 24mm eurv.eutt. 3(2/0) 70em --21 10705-19 0'11.'8942 Unieryl 26mm 1/2e.r.b. 2(3/0) 75em

22 11148-04 OW8942 Unieryl 26mm 1/2e.r.b. 2(3/0) 75em"--



25 10706-33 OW8943 Unicryl 26mm 1/2e.r.b. 3(2/0) 75em

26 10943-29 OW8943 Unieryl 26mm 1/2e.r.b. 3(2/0) 75em -----27 10777-14 OW8943 Unicryl 26mrn 1/2e.r.b. 3{2/0) 75em --28 10900-03 508300 Unieryl 26mm 5/8e.r.o.3(2/0) 75em

UNI®



29 11127-01A DW8833 Unieryl 26mm eurv.eutt. 3(2/0) 75em







36 10994-02 DW8954 Unieryl 30mm 1/2e.r.b. 3.5(0) 75em

37 10841-02 DW8954 Unieryl 30mm 1/2e.r.b. 3.5(0) 75em ----38 10879-28 DW8954 Unieryl 30mm 1/2e.r.b. 3.5(0) 75em

39 11090-45 DW8955 Unieryl 30mm 1/2e.r.b. 4(1) 75em --40 10841-06 DW8955 Unieryl 30mm 1/2e.r.b. 4(1) 75em

41 10841-15 DW881357 Unieryl 30mm eurv.cutt. 3(2/0) 75em

42 11127-03A 5D8668 Unieryl 35mm eurv.eutt. 3.5(0) 75em --43 11222-03 5D8668 Unicryl 35mm eurv.cutt. 3.5(0) 75em .,44 10801-08 5D8163 Unieryl 3Smm j.r.b. 4(1) 75em

~

45 10841-07 S 989359 Unieryl 37mm 1/2e.r.b. 4(1) 90em --46 10841-22 5D8665 Unicryl 37mm eurv.eutt. 3(2/0) 75em

47 10850-19 DW8525 Unieryl 40m~ 1/2e.eutt. 4(1) 75em- '---148 10890-01 DW85265 Unieryl 40mm 1/2e.elltt. 5(2) 70em ------.49 11154-01 DW8513 Unieryl 40mm 1/2e.r.b. 3(2/0) 75em

I

- ----------j50 10879-09 DW8513 Unieryl 40mrn 1/2e.r.b. 3(2/0) 75cm~ --_.•..•_----,,51 1031062K DW8514 Unieryl 4:Jmm 1/2e.r.h. 3.5(0) 7Scm

~. ------52 10370-62J DW8514 Unieryi 40mm 1/2e.r.b. 3.5(0) 75em -------53 10370-62N DW8514 Unieryl 40mm 1/2e.r.b. 3.5(0) 75em ----54 10370-62L DW8514 Unieryl 40mm 1/2e.r.b. 3.5(0) 75em --_._--55 11101-61E DW8514 Unieryl 40mm 1/2e.r.b. 3.5(0) 75em

56 11101-G1F DW8S14 Unieryl40mm 1/2e.r.b. 3.5(0) 75em ---~

I 57 10706-20 DW8514 Unieryl40mm i/zc.r.». 3.5(0) 75cm

58 10988-16A DW3514 Unieryl 40mrT] 1/2c.r.b. 3.5(0) 75em

.~59 10988-16 DW8514 Unieryl 40mm 1/2e.r.b. 3.5(0) 75cm

60 10777-J_2 DW8514 Unicryl 40mm 1/2e.r.b. 3.5(0) 75em

61 11205-0S DW85145 Unieryl 40mm 1/2e.r.b. 3.5(0) 90em,I

62 10706-21 DW8515 Unieryl 40mm 1/2e.r.b. 4(1) 75em-- '---'---J

- --...'.--..--~63 10846-43 DW8515 Unieryl 4Qmrn 1/2e.r.b 4(1) 75ern

~

i--

64 10705-13 DW8515 Unieryl 40rnm 1/2e.r.b. 4(1) 75em-

65 10887-22A DW8515 Unieryl 40mm 1/2e.r.b. 4(1) 75em

66 10879-01 DW8515 Unieryl40mrn 1/2e.r.b. 4(1) 75em I67 11044-15 DW8516 Unicryl 40mm 1/2e.r.b. 5(2) 75em

j1----68 10943-31 DW8516 Ur:ieryl 40mm 1/2c.r.b. 5(2) 75em

[ 69 10988-17 DW8516 Unieryl40mm 1/2e.r.b. 5(2) 75em

70 10850-20 DW8516 Unieryl4Cmm 1/2e.r.b._~_2) 75em--

UNI®



71 11116-33 DW8514H Unicryl 40mm 1/2c.r.b.hvy. 3.5(0) 75cm

72 11175-38 DW8524R Unicryl 40mm 1/2c.rev.cutt. 3.5(0) 75cm

73 10943-32 DW8525R Unicryl 40mm 1/2c.rev.cutt. 4(1) 75cm


75 11121-028 5D8189 Unicryl 40mm curv.cutt. 4(1) 75cm

76 10904-01 DW8854 Unicryl 45mm 1/2c.r.b.hvy. 3.5(0) 75cm -77 10826-02 DW8855 Unicryl 45mm 1/2c.r.b.hvy. 4(1) 75cm

78 10826-03 DW8856 Unicryl 45mm 1/2c.r.b.hvy.5(2) 75cm

79 10846-47 DW8856 Unicryl 45mm 1/2c.r.b.hvy.5(2) 75cm --80 10777-09A 5D8070 Unicryl 48mm 1/2c.cutt. 4(1) 75cm

81 11118-22 5D8070 Unicryl 48mm 1/2c.cutt. 4(1) 75cm

82 10850-29 SD8118 Unicryl 48mm 1/2c.r.b. 3.5(0) 90cm

83 10879-07 5D8118 Unicryl 48mm 1/2c.r.b. 3.5(0) 90cm

84 10879-05 59849 Unicryl48mm 1/2c.r.b. 4(1) 75cm

~85 10850-32 59849 Unicryl48mm 1/2c.r.b. 4(1) 75cm

86 10841-09 SD8061 Unicryl48mm 1/2c.r.b. 4(1) 90cm 187 10879-06 DW8554 Unicryl 50rnm 1/2c.r.b. 3.5(0) 75cm =188 10841-20 DW85715 Unicry! 60mmstr.cutt. 1.5(4/0) 67cm I

.----.89 10841-21 DW8573 Unicryl 60mm str.cutt. 3(2/0) 75cm

90 10777-13 DW8573 Unicryl 60mm_str.cutt. 3(2/0) 75cm

91 10841-19 DW8627D Unicryl 6mm curv.spat.d/a 0.4(8/0) 30cm

92 10839-13 DW8628D5 Unicryl 6mm curv.spat.d/a.0.5(7/0) 45cm

93 11090-28 DW8504 Unicryl cut lengths 3.5(0) 1.5m_. --94 11174-10 DW8505 Unicryl cut lengths 4(1) 1.5m- ----95 11044-12 DW8503 Unicryi cut lengths 3(2/0) 1.5 metres_. ---j

~10708-04 DW8503 Unicryl cut lengths 3(2/0) 1.5 metres

--~97 10841-16 DW8503 Unicryl cut lengths 3(2/0) 1.5 metres-98 10423-37 DW88605U Unicryl (ud) 16mm curv.cutt. 1(5/0) 45cm I- ,

I

99 10500-36 DW88615U Unicryl (Lid) 16mm curv.cutt. 1.5(4/0) 45cm ---_.-100 10501-01 DW88615U Unicryl (ud) 16mm curv.cutt. 1.5(4/0) 45cm- --101 10308-11 DW8861RU Unicryl (ud) 16mm curv.rev.cutt. 1.5(4/0) 75cm- --102 10308-10 DW8860RU Unicryl (ud) 16rtnn r.urv.rev.cutt.1(5/0) 75cm --_.__._-103 10523-01 DW8900U Unicryl (ud) 19mm curv.cutt. 1(5/0) 75cm --104 10267-73 DW89015U Unicryl (ud) 19011mcurv.cutt. 1.5(4/0) 45cm

105 10523-02 DW8901U Unicryl (ud) 19mm curv.cutt.I.Sla/O) 75cm

106 10633-16 DW890lU Unicryl (ud) 19mm curv.cutt.1.5(4!0) 75cm -----107 10140-8C DW8937RU Unicryl (ud) 24mrn curv.rev.cutt. 2(3/0) 75cm

108 10267-54 DW8832R5U7 Unicry! (ud) 26mm curv.rev.cutt. 2(3/0) 75cm I109 10011-07 DW8832RSU7 Unicryl (ud) 26mm curv.rev.cutt. 2(3/0) 75cm

110 10062-15 DW8833R57U Unicryl (ud) 26mm curv.rev.cutt. 3(2/0) 75cm .-.--~111 10174-68 DW8833R57U Unicryl (ud)26rnm curv.rev.cutt. 3(2/0) 75cm

-

UNI®

Head Office P.O.Box 51B71Riyadh 11553Saudi ArabiaTel: +966 11 265 0665Fax: +966 11 265 [email protected]





115 10186-01 DW8881R Unicryl12mm curv.rev.cutt. 1.5(4/0) 75cm

Unicryl16mm 1/2c.r.b. 1 (5/0) 75cm I .-116 10389-12 DW8800

117 10331-01 DW8861 Unicryl16rnm curv.cutr. 1.5(4/0) 75crr.

118 10140-50 5D81145 Unicryl19mm 1/2c.eutt. 1.5(4/0) 75cm

119 10170-04 DW8902R Unieryl19mm curv.rev.cutt. 2(3/0) 70cm

J.20 10203-43 DW8902R Unicryl 19rnm curv.rev.cutt. 2(3/0) 70cm

121 10319-06 5E 663 Unicryl 20mm 1/2c.cutt. 1.5(4/0) 75cm

122 10112-11 5E 365 Unicryl 20mm 1/2c.cutt. 2{3/0) 75cm --123 10247-03 DW8921 Unicryl 20mm 1/2c.r.b. 1.5(4/0) 75cm

124 10062-17 DW8921 Unieryl 20mm 1/2c.r.b. 1.5(4/0) 75cm ----125 10140-53 DW8921 Unicryl 20mm 1/2c.r.b. 1.5(4/0) 75cm .126 10174-74 DW8921 Unicryl 20mm 1/2e.r.b. 1.5(4/0) 75cm --127 10500-26 DW8921 Unicryl 20mm 1/2e.r.b. 1.5(4/0) 75cm -----128 10518-02 DW8921 Unicryl 20mm 1/2c.r.b. 1.5(4/0) 75cm

129 10171-06 DW8922 Unicryl 20mm 1/2e.r.b. 2(3/0) 75cm .-130 10140-52 DW8922 Unicryl 20mm 1/2c.r.b. 2(3/0) 75cm

r--- --------131 10500-25 DW8922 Unieryl 20mrr. 1/2c.r.b.:,2(3/0) 75em .-132 10769-03 DW8922 Unicryl 20mm 1/2e.r.b. 2(3/0) 75cm ----_.133 10469-01 DW8922 Unicryl 20mm 1/2e.r.b. 2{3/0) 75cm

134 10062-19 ~8937R Unicryl 24mm curv.rev.cutt. 2(3/0) 70cm ---_.j135 10174-76 DW8937R Unicryl 24mm curv.rev.cutt. 2(3/0) 70cm

136 10137-03 DW8942 Unicryl 26r,1m 1/2c.r.b. 2(3/0) 75cm I-137 10140-55 DW8942 Unicryl 26mm 1/2c.r.b. 2(3/0) 75em' --138 10139-04 DW8942 Uni:ryl 26mm 1/2c.r.b. 2{3/0) 75cm -.~.-~---..~-~-139 10174-78 DW8942 Unicryl 26rnm 1/2c.r.h. 2(3/0) 75cm _ .._-----140 10267-53 DW8942 Unicryl 26mro 1/2c.r.b. 2(3/0) 75cm ----141 10140-54 DW8943 Unicryl 26mm 1/2c.r.b. 3(2/0) 75cm_. .---.--1112 10174-79 DW8943 Unicryl 26mm 1/2c.r.b. 3(2/0) 75cl1)

-_._-_.j--143 10267-57 DW2943 Unicryl 26mm 1/2e.r.b. 3(2/0) 75cm

144 10190-02 DW8943 Unicryl 26mi11 1/2c.r.b. 3(2/0) 75cm~145 10062-24 DW894359 Unicryl 26mrn Y2c.r.b. 3(2/0) 90cm ._-!

146 10319-04 DW8832 Unicryl 26mm curv.cutt. 2(3/0) 75cm

147 10040-07 DW8833 Unicryl 26mm curv.cutt. 3(2/0) 75cm .-._.._-----148 10363-02 DW8833 Unicryl 26mm curv.cutt. 3(2/0) 75cm -------149 10319-05 DW8833R Unicryl 26mrn eurv.rev.cutt. 3(2/0) 75cm. ---ISO 10171-05 5D8295 Unicryl 27mm 1/2c.r.b. 3(2/0) 75cm --_ ..151 10320-01 5E 206 Unicryl 30mm 1/2e r.b, 3(2/0) 90cm --------j152 10140-59 DW8952 Unicryl 30mm 1/2e.r.b. 2(3/0) 75cm -.----~.,--~--153 10137-05 DW3953 Unicryl 30mm 1/2c.r.b. 3(2/0) 75cm-

UNI®








159 10262-02 DW8953 Unicryl30mm 1/2c.r.b. 3(2/0) 75cm


Unicryl 30mm 1/2c.r.b. 3(2/0) 75cm-----

161 10488-02 DW8953

162 10091-01 DW8953 Unicryl 30mm 1/2:::.r.b. 3(2/0) 7Scm --163 10112-01 DW8954 Unicryl 30mm 1/2c.r.b. 3.5(0) 75cm

164 10140-56 DW8954 Unicryl 30mm 1/2c.r.b. 3.5(0) 75cm

165 10140-56 DW8954 Unicryl 30mm 1/2c.r.b. 3.5(0) 75cm -166 10174-82 DW8954 Unicryl 30mm 1/2c.r.b. 3.5(0) 75cm .167 10174-83 DW8955 Unicryl 30mm 1/2c.r.b. 4(1) 75cm


169 10062-29 DW8993 Unicryl 35mm 1/2c.r.b. 3(2/0) 75cm =J170 10140-60 DW8993 Unicryl 3Smm 1/2c.r.b. 3(2/0) 75cm =J171 10171-07 DW8995 Unicryl 35mm 1/2c.r.b. 4(1) 75cm

172 10062-30 DW8563 Unicryl 35mfn curv.cutt. 3(2/0) 75cm

-~173 10205-03 5D8668 Unicryl 35mm curv.cutt. 3.5(0) 75cm

174 10303-01 5E 130 Unicryl 37mm 1/2c.r.b. 3(2/0) 75cm

175 10307-01 5E 130 Unicryl 37mm 1/2c.r.b. 3(2/0) 75cm I176 10509-01 SE 130 Unicryl 37mm 1/2c.r.b. 3(2/0) 75cm .;177 I 10633-29 5E 130 Unicryl 37mm 1/2c.r.b. 3(2/0) 75cm .----1178 10303-02 59892 Unicryl 37mm 1/2c.r.b. 3.5(0) 7Scm '---j179 10194-03 598925 Unicryl 37rnm 1/2c.r.b. 3.5(0) 90cm

180 10247-02 DW8513 Unicryl 40mrn 1/2c.r.b. 3(2/0) 75cm

181 10140-67 DW8513 Unicryl 40mm 1/2c.r.b. 3(2/0) 7Scm _. __ J

182 10172-17 DW8513 Unicryl 40mri1 1/2c.r.l:1. 3(2/0) 75cm

183 10564-08 DW8513 Unicryl 40mm 1/2c.r.b. 3(2/0) 75cm .-184 9755-58G DW8514 Unicryl 40mm l/2c.r.b. 3.5(0) 75cm_. .--185 9755-58J DW8514 Unicryl 40mrn 1/2c.r.b. 3.5(0) 75cm -------186 9755-58M DW8514 Unicryl 40mm 1/2c.r.b. 3.5(0) 75cm .-187 10370-62 DW8514 Unicryl 40mm 1/2c.i-.b. 3.5(0) 75cm ._--188 10370-62C DW8514 Unicryl 40mm 1/2c.r.b. 3.5(0) 75cm =-j189 10370-62B DW8514 Unicryl 40mm 1/2c.r.b. 3.5(0) 75cm --190 10139-09 DW8514 Unicryl 40mm 1/2c.r.b. 3.5(0) 75cm

·1191 10140-65 DW8514 Unicryl 40mm 1/2c.r.b. 3.5(0) 75cm ,---,192 10488-01 DW8514 Unicryl40mm 1/2c.r.b. 3.5(0) 75cm..- --193 10190-01A-JDW8514 Unicryl40mm 1/2cJ.b. 3.5(0) 7.5cm

194 10203-15 !DW8514 Unicryl40mm 1/2c.r.b. 3.5(0) 75cm -=J195 10633-02 DW851·l Unicryl40mm 1/2c.r.b. 3.5(0) 75cm ._---

UNI®


United Medical Industries Co. ltd.

196 10194-02 DW8514S Unicryl 40mm 1/2c.r.b. 3.5(0) 90cm


198 10062-33 DW8515 Unicryl40mm 1/2c.r.b. 4(1) 75cm --199 10140-66 DW8515 Unicryl40mm 1/2c.r.b. 4(1) 75cm

200 10172-18 DW8515 Unicryl 40mm 1/2c.r.b. 4(1) 75cm -----201 10500-33 DW8515 Unicryl 40mm 1/2c.r.b. 4(1) 75cm

202 10762-01 DW8515 Unicryl40mm 1/2c.r.b. 4(1) 75cm --203 10338-03 DW8515S Unicryl 40mm 1/2c.r.b. 4(1) 90cm

204 10194-06 DW8515S Unicryl 40mm 1/2c.r.b. 4(1) SOcm

205 10172-20 DW8516 Unicryl 40mm 1/2c.r.b. 5(2) 75cm --206 10174-61 DW8516 Unicryl40mm 1/2c.r.b. 5(2) 75cm



209 10174-58 DW8514H Unicryl 40mm 1/2c.r.b.h'JY. 3.5(0) 75cm


211 10139-12 DW8515H Unicryl 40mm 1/2c.r.b.hvy. 4(1) 75crn

212 10172-19 DW8515H Unicryl 40mm 1/2c.r.b.hvy. 4(1) 75cm --213 10140-63 DW8524R Unicryl 40mm 1/2c.rev.cutt. 3.5(0) 75cm --214 10174-62 IDW8524R Unicryl 40ml1' 1/2c.rev.CL!tt. 3.5(0) 75cm

--.-~2Ei 10140-62 DW8525R Unicryl40mm 1/2c.rev.cutt. 4(1) 75cm

216 10174-63 DW8525R Unicryl 40m:TI 1/2c.rev.cutt. 4(1) 75cm ---217 10101-01 DW852SR Unicryl ·10rnm 1/2cxev.cutl. 4(1) 75cm-- .------1218 10140-64 DW8526R Unicryl 40mm l/2c.rev.cutt. 5(2) 75cm


220 1020S-01A 5D8189 Unicryl 40mm curv.cutt. 4(1) 75cm --------221 10363-01 5D8189 UnicryI40mmcurv.cutt. 4(1) 75cm ---222 10633-39 DW8855S7 Unicryl 45mm l/2c.r.b. 4(1) 75cm

223 10452-04 DW885657 Unicryl 45mm 1/2c.r.b. 5(2) 75cm --224 10399-01 DW8854 Unicryl 45mm 1/2c.r.b.hvy. 3.5(0) 75cm-- ----I

225 10452-01 DW8854 Unicryl45mm 1/2c.r.bJ~yy. 3.5(0) 75cm ---._--.J226 10376-02 DW3855 Unicryl 45rnm 1/2c.r.b.hvy. 4(1) 75cm -227 10589-01 DW8855 Unicryl 45rnm 1/2c.r.b.hvy. 4(1) 75cm--- --_._-228 10502-02 DW8856 Unicryl 45mrn 1/2c.r_b.hvy.5(2) 75cm --

! 229 10399-03 DW8856 Unicryl45mrn 1/2c.r.b.hvy.5(2) 75cm--

230 10267-64 DW8856 Unicryl 45mm 1/2c.r.h.hvy.5(2) 75cm --.-.----231 10102-01 DW8856 Unicryl45mm 1/2c.r.b.hvy.5(2) 75cm

232 10098-01 DT8536 Unicryl45mrn1/2ctapeLcut 5(2) 75cm 1_..=:J233 10062-37 DW8556 Unicryl 50mrn :tf2c.r.b. 5(2) 75c01

234 10423-27 DW8C55R Unicryl 50mm 1/2c.rev.cutt. 4(1) 75cm

Unicryl GOmm ~tr.c~tt. 2(3/0) 75cm ]-

235 10633-38 DW8S72 -------236 10138-01 DW8628D5 Unicryl6mm curv.spat.d/a.0.5(7/0) 45cm- -237 10423-29 DW8379D Unicryl8mm 1/4c.spat.d/a 0.7(6/0) 45cm ---~-----.

UNI®



238 10712-05 DW8502 Unicryl cut lengths 2(3/0) 1.5m

239 10308-06 DW8504 Unicryl cut lengths 3.5(0) 1.5m



242 10338-01 DW8503 Unicryl cut lengths 3(2/0) 1.5 metres I243 10423-33 DW8503 Unicryl cut lengths 3(2/0) 1.5 metres --

Customer ActionPlease review your inventory fOI"products affected by this issue and perform the following actions:




Please share this notificaticn with others in your organization as appropriate. If product within scope of this




If you have any questions, please contact your Unimed Rep(esentatives.

Sincerely,

Nader Hamdan Assiri

UNI®



Urgent Field Safety NoticeUnicaprone Surgical Suture Recall

Date: 13/11/2016Unimed Reference: FSN02Dear NeMDR Team





1 10370-112C DW13029V Unicaprone (violet) 22mm 1/2c.r.b. 2(3/0) 70cm

2 10370-111A DW13058V Unicaprone (violet) 30mm 1/2c.r.b. 3(2/0) 70cm

3 10370-32A DW13503V Unicaprone (violet) standard lengths 3(2/0) 1.5 metres

4 10370-32C DW13503V Unicaprone (violet) standard lengths 3(2/0) 1.5 metres .----5 10850-44 DW13013 Unicaprone 17mm curv.r.b. 1.5(4/0) 70cm

6 10860-02 DP13024 Unicaprone 19mm curv.P-type.rev.cutt. 2(3/0) 45crn

7 10846-13 DW13901RU Unicaprone 19mm curv.rev.cutt. J..5(4/0) 45cm

8 10370-107C DW13902RU Unicaprone 19mm curv.rev.cutt. 2(3/0) 45cm

9 10370-107D DW13902RU Unicaprone 19mm curv.rev.cutt. 2(3/0) 45cm

10 10846-14 DW13902RU Unicaprone 19mm curv.rev.cutt. 2(3/0) 45cm




14 10370-106C DW13833RS Unicaprone 26mm curv.rev.cutt. 3(2/0) 70cm

15 10370-106D DW1J833RS Unicaprone 26mm curv.rev.cutt. 3(2/0) 70cm -16 10370-106F DW13833RS Unicaprone 26mm curv.rev.cutt. 3(2/0) 70cm

17 10712-03 DW13572U Unicaprone 60mm str.cutt. 2(3/0) 70cm

18 10370-33 DW13573 Unicaprone 60mm str.cutt. 3(2/0) 70cm

19 9755-113C DW13801VS Unicaprone (violet) _16mm 1/2c.r.b. 1.5(4/0) 75cm -..20 9755-112B DW13029V Unicaprone (violet) 22mm 1/2c.r.b. 2(3/0) 70cm

21 9755-110B DW13058V Unicaprone (violet) 30mm 1/2c.r.b. 3(2/0) 700n --122 9755-109C DW13084V Unicaprone (violet) 36mm 1/2c.r.b. 3.5(0) 70cm

23 9755-29C DW13503V Unicaprone (viol~_t) standard lengths 3(2/0) 1.5 metres --24 9755-108F DW13760RU Unicaprone 13mm curv.rev.cutt.l(5/0) 45cm

25 10370-109B DW13760RU Unicaprone 13mm curv.rev.cutt.Hfi/O] 45cm

26 10339-03 DP13008 Unicaprone 16rnm curv.P-type.rev.cutt. 1.5(4/0) 45cm --21 10423-05 DW13861RSU Unicaprone 16mm curv.rev.cutt. 1.5(4/0) 45cm --

UNI®



28 10267-28 DW13861RSU Unicaprone 16mm curv.rev.cutt. 1.5(4/0) 45cm

29 10240-15 DW13861RS7 Unicaprone 16mm curv.rev.cutt. 1.5(4/0) 75cm




33 9755-107B DW13901RU Unicaprone 19mm curv.rev.cutt. 1.5(4/0) 45cm



36 9755-106B DW13902RU Unicaprone 19mm curv.rev.cutt. 2(3/0) 45cm --37 9755-106D DW13902RU Unicaprone 19mm curv.rev.cutt. 2(3/0) 45cm --38 10249-03 DW13902RS Unicaprone 19mm curv.rev.cutt. 2(3/0) 75cm

39 10028-32 DW13831S Unicaprone 26mm curv.cutt. 1.5(4/0) 75cm


41 10370-106A DW13833RS Unicaprone 26~m curv.rev.cutt. 3(2/0) 70cm

42 10608-03 DW13833R Unicaprone 26mm curv.rev.cutt. 3(2/0) 75cm ._____

43 10377-01 DW13058 Unicaprone 30mm 1/2c.r.b. 3(2/0) 70err, ==l44 10589-01 DT13079 Unicaprone 35mm Y2c.taper.cut. 3.5(0) 70cm

45 10062-04 DW13514S Unicaprone 40mm 1/2c.r.b. 3.5(0) 75cm ~

46 10334-01 DW13115 Unicaprone 40mm 1/2c.r.b.hvy.4(1) 70cm

47 10370-33A DW13573 Unicaplone 60mm str.cutt. 3(2/0) 70cm ______




return cf affected product as necessary.






Sincerely,

Nader Hamdan Assiri

UNI®



Urgent Field Safety NoticeUnicryl Quick Surgical Suture Recall


This letter to inform you that we have identified that the Suture Breaking Strength in few incidents arenon compliant to European Pharmacopeia requirementsWe are initiating a voluntary recall for the following batches:


1 10936-01 DP12219R Unicrylquick12mmcurv.P-type.rev.cutt.0.7(6/0) 45cm

2 10370-102B DW12220R Unicryl quick 12mm curv.rev.cutt. 1(5/0) 45cm

3 10370-101A DW12801 Unicryl quick 16mm 1/2c.r.b. 1.5(4/0) l5cm


5 10706-02 DW12861 Unicryl quick 16mm curv.cutt. 1.5(4/0) 75cm --6 11023-07 DW12902 Unicryl quick 19mm curv.cutt. 2(3/0) 75cm



9 10370-100B DW12922 Unicrvl quick 20mm 1/2c.r.b. 2(3/0} 75cm 310 10370-100D DW12922 Unicryl quick 20mm 1/2c.r.b. 2(3/0) 75cm

11 10854-01 SD12000 Unicryl quick 22mm 1/2c.r.b. 2(3/0) 75cm

12 10846-23 DW12833 Unicryl quick 26mm curv.cutt. 3(2/0) 75cm _


14 10370-98C DW12833RU Unicryl quick 26mm curv.rev.cutt. 3(2/0) 75cm

15 10370-98D DW12833RU Unicryl quick 26mm curv.rev.cutt. 3(2/0) 75cm


17 10825-03 DW12953 Unicryl quick 30mm 1/2c.r.b. 3(2/0) 75cm --18 10929-01 DT12873US9 Unicryl quick 35mm 1/2c.taper.cut. 3(2/0) 90cm

19 10881-01 DT12874S9 Unicryl quick 35mm 1/2c.tapeLcut. 3.5(0) 90cm

20 10370-95C SD12030HS Unicryl quick 36mm 1/2c.r.b.hvy. 3(2/0) 90cm

21 11101-106 SD12030HS Unicryl quick 36mm 1/2c.r.b.hvy. 3(2/0) 90cm

22 10774-01 DW12513 Unicryl quick 40mm 1/2c.r.b. 3(2/0) 75cm --23 10370-94D SD17.008H Unicryl quick 50mm 1/2.c.r.b.hvy. 3(2/0) 75cm .-----24 10370-94C SD12008H Unicryl quick 5Cmm 1/2.c.r.b.hvy. 3(2/0) 75cm

25 11101-105 SD12008H Unicryl quick 50mm 1/2.c.r.b.hvy. 3(2/0) 75cm

26 9755-103A DW12801 Unicryl quick 16n;.m1/2c.r.b. 1.5(4/0) 75cm I

Product Name: UniCryl Quick

UNI®



27 10267-39 DW12861 Unicryl q~ick 16mm curv.cutt. 1.5(4/0) 75cm


29 10183-03 DW12901R Unicryl quick 19mm curv.rev.cutt. 1.5(4/0) 75cm




33 10172-04 DW12902R Unicrvl quick 19rnm curv.rev.cutt. 2(3/0) 75cm

34 9755-102B DW12922 Unicryl quick 20mm 1/2c.r.b. 2(3/0) 75cm

35 10191-04 DW12922 Unicryl quick 20mm 1/2c.r.b. 2(3/0) 75cm

36 10062-45 DW12832S Unicryl quick 26mm curv.cutt. 2(3/0) 45cm


38 10062-46 DW12833 Unicryl quick 26mm curv.cutt. 3(2/0) 75cm -_.-39 10139-03 DW12833 Unicryl quick 26mm curv.cutt. 3(2/0) 75cm

40 10062-47 DP12832RS7 Unicryl quick 26rnm curv.P-type.rev.cutt. 2(3/~) 75~m

41 10174-03 DP12832RS7 Unicry! quick 26mm curv.P-type.rev.cutt. 2(3/0) 75cm --42 10612-01 DP12832RS7 Unicryl quick 26mm curv.P-type.rev.cutt. 2(3/0) ?~cm

43 10502-03 DW12832RS Unicryl quick 26mm curv.rev.cutt. 2(3/0) 45cm ---

=:344 9755-1008 DW12833RU Unicryl quick 26m;:n curv.rev.cutt. 3(2/0) 75cl11

45 10370·98 DW12833RU Unicryl quick 26mm curv.rev.cutt. 3(2/0) 75cm

46 9755-101A DW12953 Unicryl 9.ulck 30mm I/2c.r.b. 3(2/0) 75cm

--- ~

1-.

, 47 10721-01 DT12873US9 Unicryl quick 3Smm 1/2c.taper.cut. 3(2/0) 90cm

48 10254-01 DT12874S9 Unicryl quick 35mm 1/2c.taper.cut. 3.5(0) 90cm I--l49 10370-96 SD12062H Unicryl quick 36mm 1/2c.r.b.hvy 2(3/0) 90cm I

- --50 10370-96A SD12062H Uni~ryl quick 3Gn~m 1/2c.r.b.hvy 2(3/0) 90cm-- _. --------51 9755-97A SD12030HS Unicryl quick 36mm 1/2c.r.b.hvy. 3(2/0) 90cm- ._------52 10370-95 SD12030HS Unicryl quick 36mm 1/2c.r.b.hvy. 3(2/0) 90cm -------- ..--53 10370-95A SD12030HS Unicryl quick 36mm 1/2c.r.b.hv'l. 3(2/0) 90cm -------,54 10370-95B SD12030HS Unicryl quick 36mm 1/2c.r.b.hvy. 3(2/0) gOcm

~

55 10700-27 ST12059 Unicryl quick 36mm 1/2c.taper.cut. 3(2/0) 90crn

56 10370-94 SD12008H Unicryl quic_~50mm 1/2.c.r.b.hvy. 3(2/0) 75cm

57 10608-01 DW12573 Unicryl quick 60mm str.cutt. 3(2/0) 75cm---~

-----~. .-"-.__.- -

Head Office P.O.Box51871

UNIM ~~a~~~il3,;~u:!A~~~~

Fax: +966 11 265 0569

United Medicallnc;l.ustries Co. Ltd. www. u n i m e d. com. 5 aCustomer Action [email protected] review your inventory for products affected by this issue and perform the following actions:









Sincerely,

Nader Hamdan Assiri

UNI®



Urgent Field Safety NoticeUniglactin Surgical Suture Recall

Date:13/11/2016Unimed Reference: FSN04Dear NCMDR Team




serial Batch# Item Code Description

1 10370-60C DWl1220RSU Uniglactin (ud) 12mm curv.rev.cutt. 1(5/0) 75cm

2 10760-01A DW11860U Uniglactin (ud) 16mm curv.cutt. 1(5/0) 75cm

3 11001-01A DW11832RS7U Uniglactin (ud) 26mm curv.rev.cutt. 2(3/0) 75cm

4 10370-89L DW11219S4 Uniglactin 12mm curv.cutt. 0.7(6/0) 45cm --5 10370-89J DW11219S4 Uniglactin 12mm curv.cutt. 0.7(6/0) 45cm

6 10370-89N DWl1219S4 Uniglactin 12mm curv.cutt. 0.7(6/0) 45cm

7 10370-89R DW11219S4 Uniglactin 12mm curv.cutt. 0.7(6/0) 45cm

8 10370-83D DWl1388S4 Uniglactin 13mm curv.r.b. 1.5(4/0) 45cm --9 10370-83E DWl1388S4 Uniglactin 13mm curv.r.b. 1.5(4/0) 45cm

10 10370-831 DWl1388S4 Uniglactin 13mm curv.r.b. 1.5(4/0) 45cm

11 10370-81H DWl1389 Uniglactin 13mm curv.r.b. 2(3/0) 45cm

12 10370-81F DWl1389 Uniglactin 13mm curv.r.b. 2(3/0) 45cm .-13 10775-01 DWl1398S Unlglactin 13mm str.cutt. 1.5(4/0) 75cm --14 10370-82F DW11862 Uniglactin 16mm curv.cutt. 2(3/0) 75cm

15 10370-82K DW11862 Uniglactin 16mm curv.cutt. 2(3/0) 75cm

16 10370-82J DW11862 Uniglactin 16mm curv.cutt. 2(3/0) 75cm j17 10370-86B DW11860 Uniglactin 16mm curv.cutt. 1(5/0) 75cm

18 10370-86D DW11860 Uniglactin 16mm curv.cutt. 1(5/0) 75cm

19 10370-86E DW11860 Uniglactin 16mm curv.cutt. 1(5/0) 75cm --20 11101-96 DW11860 Uniglactin 16mm curv.cutt. 1(5/0) 75cm --21 10370-84B DW11841S Uniglactin 16mm curv.r.b. 1.5(4/0) 75cm

22 10370-80B DW11922 Uniglactin 20mm 1/2c.r.b. 2(3/0) 15cm

23 10370-80A DW11922 Uniglactin 20mm 1/2c.r.b. 2(3/0) 75cm

24 10825-04 DW11922 Uniglactin 20mm 1/2c.r.b. 2(3/0) 75cm'----- -25 11101-89 SD11008 Uniglactin 25mm 1/2c.r.b. 2(3/0) 75cm --26 11101-89G SD11008 Uniglactin 25mm I/l-c.r.b. 2(3/0) 75cm --27 11101-89F SD11008 Uniglactin 25mm l/2c.r.b. 2(3/0) 75cm

'--- --

Product Name: Uniglactin

UNI®





30 11101-830 5011021 Uniglactin 25mm 1/2e.r.b. 3(2/0) 75em

31 11101-79 0T11823 Uniglaetin 25mm 1/2c.taper.eut. 3(2/0) 75em

32 10370-75B 0T11823H Uniglaetin 25mm 1/2e.taper.eut.hvy. 3(2/0) 75em

33 10370-75C 0T11823H Uniglaetin 25mm 1/2e.taper.eut.hvy. 3(2/0) 75em

34 10370-65C SOl1170H Uniglactin 25mm 5/8e.r.b.hvy. 3.5(0) 75em

35 10370-65E S011170H Uniglaetin 2smm s/8e.r.b.hvy. 3.5(0) 75em

36 10700-05 DW11941 Uniglaetin26mm 1/2e.r.b. 1.5(4/0) 75em


38 11107-01 DW11943 Uniglaetin 26mm 1/2e.r.b. 3(2/0) 7sem

39 10700-02A OW11945 Uniglactin 26mm 1/2e.r.b. 4(1) 75em

40 11107-04 5011130 Uniglaetin 26mm 1/2e.r.b.1(s/0) 75em

41 10370-74A OW11943SA Uniglaetin 26mm(Blaek) 1/2e.r.b. 3(2/0) 70em

42 10961-02 OW11943SA Uniglaetin 26mm(Blaek) t/zc.r.b. 3(2/0) 70em --43 11101-84B OW11953 Uniglaetin 30mm 1/2er.b. 3(2/0) 7sem

44 11101-84 OW11953 Uniglaetin 30mm 1/2e.r.b. 3(2/0) 75em


46 10370-661 0\N11954 Uniglaetin 30mm 1/2e.r.b. 3.5(0) 7sem --47 10370-66H OW11954 Uniglactin 30mm 1/2e.Lb. 3.5(0) 75em

48 10310-66J DW11954 Uniglaetin 30mm 1/2e.r.b. 3.5(0) 75em

49 10J70-66N 0lN11954 Uniglaetin 30mm 1/2e.r.b. 3.5(0) 7sem

50 10370-66M OW11954 Uniglaetin 3001m l/2e.r.b. 3.5(0) 75em

~

51 10370-660 OW11954 Uniglactin 30mm 1/2e.r.b. 3.5(0) 75em

52 11101-66 OW1l954 Uniglaetin 30mm 1/2e.r.b. 3.5(0) 7sem

53 11101-G6E OW11954 Uniglaetin 30mm 1/2e.r.b. 3.5(0) 7sem

54 10370-69H OW11955 Unigiaetin 30mm 1/2e.r.b. 4(1) 75em

55 10370-69G OW11955 Uniglaetin 30mm 1/2e.r.b. 4(1) 75em

56 10370-69J DW11955 Uniglaetin 30mm 1/2e.r.b. 4(1) 7scm

57 10370-69L OW11955 ~niglaetin 30mm 1/2e.r.b. 4(1) 7sem- --58 10370-69M OW11955 Uniglaetin 30mm 1/2c.r.b. 4(1) 7sem

.-59 10370-69N DW11955 Uniglactin 30mm 1/2e.r.b. 4(1) 75em --60 10370-690 OW11955 Uniglaetir. 30mm 1/2e.r.b. 4(1) 7sem -_ ..-61 1.0370-69P OW11955 Uniglaetin 30mm l/2c.r.b. 4(1) 7sem -----62 11101-70A OW11955 Uniglactin 30mm 1/2e.r.b. 4(1) 7sem --63 10370-77A DW119530 Uniglaetin 30mm 1/2c.r.b.d/a 3(2/0) 75em--64 11101-81A OW119530 Uniglaetin 30mm 1/2e.r.b.d/a 3(2/0) 75em

65 10370-76E S011085A Unigiaetin 30mm curv.r.b, 3(2/0) 7sem

66 10370-76F S011085A Uniglaetin :;'Omm eurv.r.b. 3(2/0) 7sem

67 11101-65A SOl1171 Uniglactin 30mm eurv.r.b.3.5(O) 75em

68 11101-65 5011171 Uniglaetin 30mm eurv.r.b.3.s(0) 75em --69 11094-01 OW11993 uniglactin 3smm 1/2e.r.b. 3(2/0) 7sem--- ---

UNI®



70 11101-71 DTl1565 Uniglactin 35mm 1/2c.taper.cut.hvy. 4(1) 75cm

71 11101-71D DTl1565 Uniglactin 35mm 1/2c.taper.cut.hvy. 4(1) 75cm

72 10370-61B 5D111565 Uniglactin 36mm j.r.b. 3.5(0) 70cm

73 10370-61C 5D111565 Uniglactin 36mm j.r.b, 3.5(0) 70cm

74 10370-67V DW11514 Uniglactin 40mm 1/2c.r.b. 3.5(0) 75cm_. ..-75 10370-67Y DW11514 Uniglactin 40mm 1/2c.r.b. 3.5(0) 75cm

76 10370-67AH DW11514 Uniglactin 40mm 1/2c.r.b. 3.5(0) 75cm

77 10370-67AI DW11514 Uniglactin 40mm 1/2c.r.b. 3.5(0) 75cm

78 10370-67AF DW11514 Uniglactin 40rnm 1/2c.r.b. 3.5(0) 75cm

79 10370-67AE DW11514 Uniglactin 40mm 1/2c.r.b. 3.5(0) 75cm

80 10370-67AJ DW11514 Uniglactin 40mm 1/2c.r.b. 3.5(0) 75cm

81 10370-67AD DW11514 Uniglactin 40mm 1/2c.r.b. 3.5(0) 75cm- -82 10370-67AN DW11514 Uniglactin 40mm 1/2c.r.b. 3.5(0) 75cm --83 10370-67AK DW11514 Uniglactin 40mrn 1/2c.r.b. 3.5(0) 75cm

84 11101-67A DW11514 Uniglactin 40mm 1/2c.r.b. 3.5(0) 75cm ----85 11101-67J DW11514 Uniglactin 40mm 1/2c.r.b. 3.5(0) 75cm

86 11101-721\,1 DWl1515 Uniglactin 40mm 1/2c.r.b. 4(1) 75cm

87 11101-72A DWl1515 Uniglactin 40mm 1/2c.r.b. 4(1) 75cm --88 10834-01 DW115155 Uniglactin 40mm 1/2c.r.b. 4(1) 90cm_. -----89 11177-01A DW115155 Uniglactin 40mm 1/2c.r.b. 4(1) 90cm

90 10700-15 DW11516 Uniglactm 40mm 1/2c.r.b. 5(2) 75cm

91 10370-78D 5Dl1175 Uniglactin 40mm curv.r.b. 3(2/0) 75cm

92 10370-78H 5Dl1175 Uniglactin 40mm curv.r.b. 3(2/0) 75cm

I--93 10370-78F SDl1175 Uniglactin 40mm curv.r.b. 3(2/0) 75cm

94 11101-68 DW118555 Uniglactin 45mm 1/2c.r.b. 4(1) 75cm

95 11101-68B DW118555 Uniglactin 45mm 1/2c.r.b. 4(1) 75cm --96 10913-01 DW11855B5 Uniglactin 45mm 1/2c.r.b.blunt. 4(1) 90cm

97 10370-71N DTl1536 Uniglactin 45mm 1/2c.taper.cut. 5(2) 75crn --98 10370-71P DT11536 Uniglactin 45mm 1,/2c.taper.cut. 5(2) 75cm I--99 10370-71Q DTl1536 Uniglactin 45mm 1/2c.taper.cut. 5(2) 75cm --100 10370..71V DTl1536 Uniglactin 45mm 1/2c.taper.cut. 5(2) 75cm --101 10370-71U DTl1536 Unigiactin 45mm 1/2c.taper.cut. 5(2) 75cm

102 10370-71AA DTl1536 Uniglactin 45mm 1/2c.taper.cut. 5(2) 75cm

103 10370-71Y DTl1536 Uniglactin 45mm 1/2c.taper.cut. 5(2) 75cm

104 10370-71AB DT11536 Unlglactin 45mm 1/2c.taper.cut. 5(2) 75cm

105 10370-71X DTl1536 Uniglactin 45mm 1/2c.taper.cut. 5(2) 75cm --106 10370-71AD DTl1536 Uniglactin 45mm 1/2c.taper.cut. 5(2) 75cm

1-. --107 10370-71AC DTl1536 Uniglactin 45mm 1/2c.taper.cut. 5(2) 75cm

108 10370-71Z DTl1536 Uniglactin 45mm 1/2c.taper.cut. 5(2) 75cm --109 10370-71AI DTl1536 Uniglactin 45mm 1/2c.taper.cut. 5(2) 75cm --110 10370-71AG DTl1536 Uniglactin 45mm 1/2c.taper.cut. 5(2) 75cm

111 10370-71AH DTl1536 Unlglactin 45mm 1/2c.taper.cut. 5(2) 75cm ____J

UNI®



112 10370-71AE DTl1536 Uniglactin 45mm :"/2c.taper.cut. 5(2) 75cm

113 11101-74E DTl1536 Uniglactin 45mm 1/2c.taper.cut. 5(2) 75cm

114 11101-74A DTl1536 Uniglactin 45mm 1/2c.taper.cut. 5(2) 75cm --115 11101-74C DTllS36 Uniglactin 45mm 1/2c.taper.cut. 5(2) 75cm

116 11101-74B DTl1536 Uniglactin 45mm 1/2c.taper.cut. 5(2) 75cm

117 10986-01 DTl1536H Uniglactin 45mm 1/2c.taper.cut.hvy. 5(2) 75cm

118 10700-18 5D11155 Uniglactin 48mm 1/2c.r.b. 5(2) 75cm

119 10370-631 DW11554 Uniglactin 50mm 1/2c.r.b. 3.5(0) 75cm

120 10370-63H DW11554 Uniglactin 50mm 1/2c.r.b. 3.5(0) 75cm

121 10370-63J DW11554 Uniglactin 50mm 1/2c.r.b. 3.5(0) 75cm

122 10370-63K DW11554 Uniglactin SOmm 1/2c.r.b. 3.5(0) 75cm

123 11101-62A DW11554 Uniglactin 50mm 1/2c.r.b. 3.5(0) 75cm

124 10370-59C DW11555 Uniglactin 50mm 1/2c.r.b. 4(1) 75cm

125 10370-59D DW11555 Uniglactin 50mm 1/2c.r.b. 4(1) 75cm

126 10370-59F DW11555 Uniglactin 50mm 1/2c.r.b. 4(1) 75cm

127 10370-59H DW11555 Uniglactin 50mm 1/2c.r.b. 4(1) 75cm

128 11101-58B DW11555 Uniglactin 50mm 1/2c.r.b. 4(1) 75cm ---129 10370-68B 5D11172BH Uniglac~in 5.9mm 1/2c.r.b.blnt.hvy.4(1) 75cm ..-130 10370-68D 5D11172BH Unlglactin 50mm 1/2c.r.b.blnt.hvy.4(1) /5cm -----131 10370-791 DW11573 Uniglactin 60mm str.cutt. 3(2/0) 75cm

!- 132 10370-79H DW11573 Uniglactin 60mm str.cutt. 3(2/0) 75cm

133 10370-79l DW11573 Uniglactin 60mm str.cutt. 3(2/0) 75cm ------134 10370-790 DW11573 Uniglactin 60mm str.cutt. 3(2jO) 75cm~.135 10370-79Q DW11573 Uniglactin 60mm str.cutt. 3(2/0) 75cm --136 10370-79P D'N11573 Uniglactin 60mm str.cutt. 3(2/0) 75cm -'--J137 10370-79R DW11573 Uniglactin 60mm str.cutt. 3(2/0) 75cm -_.-138 11101-85 DW11573 Uniglactin 60mm str.cutt. 3(2/0) 75cm I-----139 10370-72B 5D11174 Uniglactin 65mm curv.r.b. 3(2/0) 75cm --140 10370-64C 5D11169 Uniglactin 65mm curv.r.b. 3.5(0) 75cm -------141 10370-640 5011169 Uniglactin 65mm rurv.r.b. 3.5(0) 75cm

142 11101-63 5D11169 Uniglactin 65mm curv.r.b. 3.5(0) 7Scm

143 10370-93F 50110535 Uniglactin 8mm 1/2c.rev.cutt. d/a O.4(B/O) 45cm..-

144 10370-91F 5D11121RO Uniglactin Brr.rn 1/2c.rev.cutt.d/a 0.5(7/0) 45cm- -----.=,------ --145 10370-92F DW116675 Uniglactin Bmm curv.r.b. 0.4(8/0) 30cm ._--146 10370-105A DW11462 Uniglactin cut lengths 2(3/0) 10x50cm

147 10370-105B DW11462 Uniglactin cut lengths 2(3/0) 10x50cm --148 11101-116 OW11462 Uniglactin cut lengths 2(3/0) 10xSOcm -.-149 10370-104B DW11463 Uniglactin cut lengths 3(2/0) 10x50cm ----150 11101-115A DW11463 Uniglactin cut lengths 3(2/0) 10x50cm -----151 10370-73C DW11503 Uniglactin cut lengths 3(2/0) 1.~ metres ------152 10370-73E DW11503 Uniglactin cut length.s 3(2/0) 1.5 metres ------153 11101-76 OW11503 IUniglactin cut lengths 3(2/0) 1.5 metresL..--. -------

UNI®

Head Office P.O.Box 51871

Riyadh 11553 Saudi Arabia

Tel: +966 11 265 0665

Fax: +966 11 265 0569www.unimed.com.sa

[email protected] Medical Industries Co. Ltd.

--154 10918-01 DW11503 Uniglactin cut lengths 3(2/0) 1.5 metres

155 10370-103B DW11464 Uniglactin cut lengths 3.5(0) 10x50cm

156 10760-01 OW11860U Uniglactin (ud) 16mm curv.cutt. 1(5/0) 75cm

157 10358-01 OP119025U Uniglactin (ud) 19mm curv.P-type.cutt. 2(3/0) 45cm

158 10578-01 5D1109154UE Uniglactin (ud) 20mm curv.extra.cutt. 2(3/0) 45cm

159 9755-93N 501100154 Uniglactin 13mm 1/2c.r.b. 0.7(6/0) 45cm

160 9755-93Q 501100154 Uniglactin 13mrr. 1/2c.r.b. 0.7(6/0) 45cm

161 9755-89F OW1138754 Uniglactin 13mm curv.r.b. 1(5/0) 45cm

162 9755-89E OW1138754 Uniglactin 13mm curv.r.b. 1(5/0) 45cm -163 9755-89G OW1138754 Uniglactin 13mm curv.r.b. 1(5/0) 45cm --164 9755-89J OW1138754 Uniglactin 13mm curv.r.b. 1(5/0) 45cm -

~-165 9755-85E OW1138854 Uniglactin 13mm curv.r.b. 1.5(4/0) 45cm

166 9755-85H DW1138854 Uniglactin 13mm curv.r.b. 1.5(4/0) 45cm --167 9755-82H OW11389 Uniglactin 13mm curv.r.b. 2(3/0) 45cm

168 9755-82G DW11389 Uniglactin 13mm curv.r.b. 2(3/0) 45cm --169 10555-01 OW11800 Uniglactin 16mm 1/2c.r.b. 1 (5/0) 75cm -----170 9755-83F OW11862 Unlglactln 16mm curv.cutt. 2(3/0) 75cm

171 9755-83L OW11862 Uniglactin 16mm curv.cutt. 2(3/0) 75cm

172 97S5-90G OW11860 Uniglactin 16mm curv.cutt. 1(5/0) 75cm ---_.-173 9755-87J OW11861 Uniglactin 16mm curv.cutt. 1.5(4/0) 75cm --174 9755-87i OW11861 Uniglactin 15mm curv.cutt. 1.5(4/0) 75cm ---175 9755-87L OW11861 Uniglactin 16mm curv.cutt. 1.5(4/0) 75cm

-~

876 9755-84K 5011008 Uniglactin 7.5mm 1/2c.r.b. 2(3/0) 75cm -----177 9755-84G 5011008 Uniglactin 25mm 1/2c.r.b. 2(3/0) 75cm

- 178--

9755-84N 5011008 Uniglactin 25mm 1/2c.r.b. 2(3/0) 75cm-~ 179 9755-840 5011008 ~~iglactin 25mm l/Lc.r.b. 2(3/0) 75cm

180 9755-78Z 5011021 Uniglactin 25mm 1/2c.r.b. 3(2/0) 75cm

181 9755-780 5011021 Uniglactin 25mm 1/2c.r.b. 3(2/0) 75cm J182 9755-78X 5011021 Uniglactin 25mm l/2c.r.b. 3(2/0) 75cm --183 9755-78Y 5D11021 Uniglactin 25mm J/2c.r.b. 3(2/0) 75cm-- --184 9755-78Q 5011021 Uniglactin 25mm 1/2c.r.b. 3(2/0) 75cm --185 9755-78W 5011021 Uniglactin 25mm 1/2c.r.b. 3(2/0) 75cm

186 10431-01 5011021 Uniglactin 25rnm 1/2c.r.b. 3(2/0) 75cm

187 9755-74E 0T11823H Uniglactin 25mm 1/2c.taper.cut.hvy. 3(2/0) 75cm



~190 9755-79F OW11953 Uniglactin 30mm 1/2c.r.b. 3(2/0) 75cm

191 10390-04 DW11953 Uniglactin 30mm l/~c.r.b. 3(2/0) 75cm

192 9755-63K DW11954 'Uniglactin 30m~ 1/2c.r.b. 3.5(0) 75cm --193 9755-63J OW11954 Uniglactin 30mm 1/2c.r.b. 3.5(0) 75cm

194 10370-66A OW11954 Uniglactin 30mm 1/2c.r.b. 3.5(0) 75cm--

195 9755-67L OW11955 Uniglactin 30mm 1/2c.r.b. 4(1) 75cm I --

UNI®



196 9755-67K DW11955 Uniglaetin 30mm 1/2e.r.b. 4(1) 75em

197 9755-67M DW11955 Uniglaetin 30mm 1/2e.r.b. 4(1) 75em

198 9755-670 DW11955 Uniglaetin 30mm 1/2e.r.b. 4(1) 75em

199 10370-69C DW11955 Uniglaetin 30mm 1/2e.r.b. 4(1) 75em --200 10370-69D DW11955 Uniglaetin 30mm 1/2e.r.b. 4(1) 75em

201 10370-69A DW11955 Uniglactin 30mm 1/2e.r.b. 4(1) 75em

202 9755-76D DW11953D Uniglaetin 30mm 1/2e.r.b.d/a 3(2/0) 75em

203 9755-75B 5D11085A Uniglaetin 30mm eurv.r.b. 3(2/0) 75em --204 9755-75E 5D11085A Uniglaetin 30mm eurv.r.b. 3(2/0) 75em

205 10370-76A 5D11085A Uniglaetin 30mm curv.r.b. 3(2/0) 75em

206 9755-62B 5Dl1171 Uniglaetin 30mm eurv.r.b.3.5(0) 75em

207 9755-62C 5Dl1171 Uniglaetin 30l11m curv.r.b.3.5(0) 75el11

208 9755-68J DT11565 Uniglaetin 35mm 1/2e.taper.eut.hvy. 4(1) 75em 1209 9755-68K DT11565 Uniglaetin 35mm 1/2e.taper.eut.hvy. 4(1) 75em --210 9755-681\1 DT11565 Uniglactin 35mm 1/2c.taper.eut.hvy. 4(1) 75em -211 10370 ..61A 5Dl11565 Uniglactin 36mm j.r.b. 3.5(0) 70em

212 9755-64M DW11514 Uniglaetin 40mm J./2e.r.b. 3.5(0) 75em-213 9755-6L1T DW11514 Uniglaetin 40mm 1/2e.r.b. 3.5(0) 75em ---214 9755-611R DW11514 Uniglaetin 40mm l/Le.r.b. 3.5(0) 75em- -- - --215 9755-541\G DW11514 Uniglaetin 40ml11 1/2e.r.b. 3.5(0) 75em

216 9755-64A,£o, DW11514 Uniglactin 40mm 1/2c.r.b. 3.5(0) 75em

~217 9755-647 DW11514 Uniglactin 40mm 1/2c.r.b. 3.5(0) 75el11

218 10370-67C DW11514 Uniglaclin 40mm 1/2e.r.b. 3.5(0) 75el11-t--. .--~-

219 10370-67G DW11514 Uniglactin 40ml11 1/2e.r.b. 3.5(0) 75el11 ---220 10370-67F DW11514 Uniglaetin 40mm 1/2e.r.b. 3.5(0) 75cm

221 103l0-67H DW11514 Uniglaetin 40mm 1/2e.r.b. 3.5(0) 75em --222 10370-67D DW11514 Uniglaetin 40l11m 1/2e.r.b. 3.5(0) 75em

223 9755-695 DW11515 Uniglaetin 40mm 1/2e.r.b. 4(1) 75em--224 9755··69W D\V11515 Unigl~etin 40mm 1/2e.r.b. 4(1) 75em

--. ---225 9755-69V DW11515 Uniglactin 40mm 1/2c.r.b. 4(1) 75cl11

-226 9755·G9T DW11515 Uniglactin 40mm 1/2c.r.b. 4(1) 75cm

227 9755-69X DW11515 Uniglactin 40mm 1/2c.r.b. 4(1) 75cm-228 9755-69Q DW11515 Uniglactin 40mm 1/2c.r.b. 4(1) 75cm -229 9755-69U DW11515 Uniglactin 40l11m 1/2c.r.b. 4(1) 75cl11

230 9755-69AG DW11515 Uniglactin 40mrn J./2c.r.b. 4(1) 75cm -----231 10305-02 DW11515 Uniglactin 40mm 1/2c.r.b. 4(1) 75cm

232 10390-01B DW11515 Uniglactin 40rnm 1/2c.r.b. 4(1) 75cm

233 10357-06 DW115155 Uniglaetin 40mm 1/2c.r.b. 4(1) 90cm

234 9755-77F 5Dl1175 Unigiactin 40mm curv.r.b. 3(2/0) 75::m ----235 9755-65H DW118555 Uniglac:tin 45mm 1/2c.r.b. 4(1) 75cm

236 9755-65L DW118555 Uniglactin 45mm 1/2c.r.b. 4(1) '15cm --237 9755-71i DT11536 Uniglactin 45mm 1/2c.taper.cut. 5(2) 75cm _J-

UNI®



238 9755-71H DT11536 Uniglaetin 45mm 1/2e.taper.eut. 5(2) 75em

239 9755-71M DT11536 Uniglaetin 45mm 1/2e.taper.eut. 5(2) 75em

240 9755-71N DT11536 Uniglaetin 45mm 1/2e.taper.eut. 5(2) 75em-241 9755-71U DT11536 Uniglaetin 45mm 1/2e.taper.eut. 5(2) 75em


243 9755-71K DT11536 Uniglaetin 45mm 1/2e.taper.cut. 5(2) 75em

244 9755-71W DT11536 Uniglaetin 45mll1 1/2c.taper.eut. 5(2) 75em

245 9755-71V DT11536 Uniglaetin 45mm 1/2e.taper.eut. 5(2) 75em

246 10370-71A DT11536 Uniglaetin 45mm 1/2e.taper.eut. 5(2) 75em

247 10370-71i DT11536 Uniglaetin 45mm 1/2e.taper.eut. 5(2) 75em

248 10370-71H DT11536 Uniglaetin 45mm 1/2e.taper.eut. 5(2) 75em -249 10370-71G DT11536 Uniglaetin 45mm 1/2e.taper.eut. 5(2) 75em-250 10370-71F DT11536 Uniglaetin 45mm 1/2e.taper.eut. 5(2) 75em


252 10305-01 DT11536 Uniglaetin 451l1m 1/2e.taper.eut. 5(2) 75em

253 10700-17 5D11075 Uniglaetin 48mm 1/2e.r.b. 4(1) 75em I -254 9755-59G DW11554 Uniglaetin 50mm 1/2e.r.b. 3.5(0) 75em ---255 9755-59i DW11554 Uniglaetin 50mm 1/2e.r.b. 3.5(0) 75em

--=J256 10370-63A DW11554 Uniglactin 50mm 1/2e.r.b. 3.5(0) 75em

257 10370-63 D'N11554 Uniglactin SOmm 1/2e.r.b. 3.5(0) 75em '---1-Uniglactin 50mm 1/2e.~.b. 4(1) 75em I258 10370-59 DW11555

259 10633-34 DW1155659 Uniglaetin 50mm 1/2e.r.b. 5(2) 90ern I -I260 9755-80i DW11573 Uniglaetin 60mm str.cutt. 3(2/0) 75em

261 9755-80J DW11573 Uniglaetin 60mm str.eutt. 3(2/0) 75em

262 9755-80K DW11573 Uniglaetin 60mm str.cutt. 3(2/0) 75em --263 975S-80U DW11573 Uniglaetin 60mrn str.eutt. 3(2/0) 75em

264 9755-805 DW11573 Uniglaetin 60mm str.eutt. 3(2/0) 75em-265 10370-79 DW11573 Uniglaetin 60mm str.eutt. 3(2/0) 75em- --266 10370-79E DW11573 Uniglaetin 60mm str.eutt. 3(2/0) 75em

..-267 10370-72A 5D11174 Uniglaetin 651l1m curv.r.b. 3(2/0) 75em -----268 10506-02 DW1l627D Uniglaetin 6mm eurv.spat.d/a 0.4(8/0) 30em --269 9755-96P SDll0535 Uniglactin Smrn 1/2e.rev.eutt. d/a 0.4(8/0) 45c:m ._---270 9755-94H 5DUI21RD Uniglactin Brnrn 1/2e.rev.eutt.d/a 0.5(7/0) 45cI11

271 9755-88G DW11380D Uniglaetin 81l1m 1/4e.spat.d/a 1(5/0) 45em ~=~Jf----- --272 9755-88N DWI13800 Uniglactln 8mm 1/4e.spat.d/a 1(5/0) 45em

273 10375-02 DW11379D5 Uniglaetin 8mm 1/4c.spat.d/a. 0.7(6/0) 20em

274 9755-95E OW116675 Uniglaetin 8mm eurv.r.b. 0.4(8/0) 30em

27S 9755-95F OW116675 Uniglaetin 8mm eurv.r.b. 0.4(8/0) 30em

276 9755-95L OW116675 Uniglaetin 8mm curv.r.b. 0.4(8/0) 30em1---

277 975S-91E DW11369 Uniglaetin Bmm curv.r.b. 0.7(6/0) 30em --l278 10370-73 DW11503 Uniglaetin cut lengths 3(2/0) 1.5 metres ]279 10370-103 DW11464 Uniglaetin cut lengths 3.5(0) 10x50em

UNl.Head Office P.O.Box51871Riyadh 11553Saudi ArabiaTel: +966 11 265 0665Fax: +966 11 265 [email protected]



1. Immediately identify and quarantine all unused. affected products in your inventory.

2. Return all unused. affected products in your inventory to Unimed. Our Representatives will assist you in the







Sincerely,

Nader Hamdan Assir!

UNI®


Urgent Field Safety NoticeUnicryl M Surgical Suture Recall







1 10370·38B OW1080057 Unicryl M 1Gmm 1/2c.Lb. 1(5/0) 70cm

2 10971·01 DW1080057 Unicryl M 16mrn 1/2e.Lb. 1(5/0j 7aem

3 10370-370 DW10801 Unieryl M 16mm 1/2e.Lb. 1.5(4/0) lOem

4 10925-01 . OW10861 Unieryl M 16mm curv.cutt. 1.5(4/0) 70em

5 10370-49B 5010040 Unieryl M 2Smm 1/2e.r.b. 1(5/0) 75em- -6 10370-49C 1,)010040 Unieryl M 2Smm 1/2e.r.b. 1(5/0) 7Sem

r--' -7 10370-48B 501003457 Unieryl M 25mrn 1/2e.Lb. 1.5(4/0) 75em

8 10370-46 SD10036 Unicryl rv~25mm 1/2r..r.b. 2(3/0) 75em-'

9 10370-46A 5010036 Unicryl M 25mm J/2t.r.b. 2(3/0) 75em

10 10370-46H 5010036 Unicrvl M 25m!:!~~c..:~_.b. 2{3/0) 75cmf------11 10370-47A DW1.09525 Unicryl M 30m;-n 1/2e.r.b.}(3/0) 7Scm_.12 11101-44A OW109525 Unicryl M 30mm l/2e.r.b. 2(3/0) 75cm

13 1082Y-01 OW10953 Unicryl M 30m~_y2c.r.b. 3(2/0) 70cm

~----

14 10370-44C OW109535 Unicryl IVI 30mm 1/2e.r.b. 3(2/0) 75cm

15 10370-440 OWI09535 Unieryl r.ll 30mm 1/2e.r.b. 3(2/0) 75cmi

16 11214-01 OW10954 Unieryl M 30mm 1/2e.Lb. 3.5(0) 70em

17 11169-01 DW10954 Unieryl M 30mm 1/2e.Lb. 3.5(0) 70cm

18 10370-410 5D10149 . Unicryl M 360101 1/2e.Lb. 3.5(0) 90cm---19 10370-41E SD10149 Unieryl M 36mm 1/2e.r.b. 3.5(0) 90em .---20 10846-07 OW10514 UnicrylM 40ml1" l/2er.b. 3.5(0) 70cm --21 11044-03 OWI0515L51 Unicryl M 40mm 1/lc.r.b. 4(1) 1.501 loop

22 10839-02 DW10515 Unicryl M 40m;" 1/2e.r.b. 4(l) 90cm I23 11076-01 DT1041759 Unieryl M 40mm 1/Le.tapeLeutA(l) 90em

24 10370-070 DWIOO64L5 UnicrylM 50mm V2c.r.b. 3.5(0) 15m loop

25 10370-07E DW10064L5 Unicrvl M 50mm 1/2e.Lb. 3.5(G) l.5m loop

26 9755-35,'\ OW1080057 Unicryl M 16mm 1/2e.r.b. 1(5/0) 70cm_. --27 9755-46D 5010040 Unieryl M 25mm 1/2e.r.b. 1(5/0) 75cm

28 10370-49 5010040 Unicryl M 25mm l/2e.r.b. Wi/OJ 75cm-------., ,29 10370-4?.-l5DIO~~0 UniC(.~ 25r:!:~1/2e.r.b. 1(5/0) 75cm

UNI®



30 9755-45A 5D1003457 Unicryl M 25mm 1/2c.r.b. 1.5(4/0) 75cm

31 9755-45B 5D1003457 Unicryl M 25mm 1/2c:!.b. 1.5(4/0) 7Scm

32 9755-43B 5D10036 Unicryl M 25mm 1/2c.r.b. 2(3/0) 75cm

33 9755-43C 5D10036 Unicryl M 25mm 1/2c.r.b. 2(3/0) 75cm

34 10467-01 5D10010 Unicryl M 25mrn 1/2c.r.b. 3(2/0) 70cm

35 10657-03 DW109435 Unicryl M 26mm 1/2c.r.b. 3(2/0) 75cm

36 10370-45 DW1094359A Unicryl M 26mm(Black) 1/2c.r.b. 3(2/0) 90cm

37 9755-44C DW109525 Unicryl M 30mm 1/2c.r.b. 2(3/0) 75cm_.38 10306-04 DW10953 Unicryl M 30mm 1/2c.r.b. 3(2/0) 70cm

39 975S-41C D'N109535 Unicryl M 30rnm 1/2c.r.b. 3(2/0) 75cm

40 10370-44 DW109535 Unicryl M 30mm l/Lc.r.b. 3(2/0) 75cm ,41 10370-44A DW109535 Unicryl M 30mm 1/2c.r.b. 3(2/0) 75cm

42 9755-38C 5D10149 Unicryl M 36mm 1/2c.r.b. 3.5(0) 90cm

43 10370-41A 5D10149 Unicryl M 36mm 1/2c.r.b. 3.5(0) 90cm-- --44 9755-408 5D10151 Unicryl M 36mm l/2c.r.b. 4(1) 90cm

45 9755-40C 5D10151 Unicryl M 36mm 1/2c.r.b. 4(1) 90cm-46 10370-43 5D10151 Unicryl M 36mm 1/2c.r.b. 4(1) 90cm---47 10370-43A 5D10151 Unicryl M 36mm 1/2c.r.b. 4(1) 90cm-48 10284-05 DW10515 Unicryl M 40mm 1/2c.r.b. 4(1) 90crn --I

t

49 10685-04 DWI051S ~~icryl M~Ornrn 1/2c.r.o. 4(1) 90cm C--_._--50 10486-01 DW10514LHS Unicrvl M 40mm 1/2u.b.hvy. 3.5(0)1.5m loop j51 10562-01 DTlO41759 Unicryl M 40mm 1/2c.taper.cut.4(1) 9Ccm



2. Return all unused, affected products in your inventory to Unimed. Our Representatives wil! assist you in the

return of arfe•.led product ~.i necessary.

Please share this notification with others in ycur organization as appropriate. If product within scope (If this




If you have anv questions, please contact your Unimed Reoresentatives.

safety communication action required - sfda.gov.sa alerts/(sg-1810-21... · unimed has initiate a...

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