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U.S. Department of Health and Human Services

Enforcement Report - Week of March 13, 2013

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Event Detail

Event ID 63282
Product Type Biologics
Status Ongoing
Recalling Firm Ethicon, Inc.
City Somerville
State NJ
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-09-27
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide and Foreign (Canada, Israel, Singapore, and Switzerland)

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Fibrin Sealant (Human) Evicel Rx Only Sterile Disposable Single Use Distributed by: Johnson and Johnson Wound Management A division of Ethicon Inc. Johnson & Johnson Wound Management A division of ETHICON, INC. P.O. Box 151, Somerville, NJ 08876-0151 USA Manufacturer: omrix Omrix biopharmaceuticals, Ltd. MDA blood bank, Sheba Hospital Ramat-Gan POB 888, Kiryat Ono 55000 ISRAEL NDC 63713-390-55 for EVICEL Fibrin Sealant (Human) 5 mL NDC 63713-390-11 for EVICEL Fibrin Sealant (Human) 1 mL NDC 63713-390-22 for EVICEL Fibrin Sealant (Human) 2 mL 5 mL sample PRODUCT CODE S3905 LOT NUMBERS Q02F010, Q05F120, Q19F420, Q35F780, Q33F700 1 mL PRODUCT CODE 3901 LOT NUMBERS Q44F97K, Q53F350 2 mL PRODUCT CODE 3902 LOT NUMBERS Q03F030, Q09F310, Q29F610, Q44F980, Q31F640, Q35F750, Q36F820, Q46F040, Q47F050 5 mL PRODUCT CODE 3905 LOT NUMBERS P44F050 P45F100 P45F090 P46F120 P48F180 R06F130 R07F180 R07F190 R07F250 R07F260 R10F310 P50F330 R10F320 R10F330 R12F380 P48F190 P53F390 Q03F040 P50F310 Q02F010 P52F370 Q11F320 P52F360 Q02F020 Q04F090 Q04F100 Q04F110 Q05F120 Q32F660 Q05F130 Q05F140 Q06F160 Q06F170 Q07F210 Q08F280 Q08F290 Q16F400 Q08F300 Q13F340 Q33F710 Q13F350 Q14F360 Q14F370 Q15F380 Q15F390 Q19F410 Q28F560 Q19F420 Q21F470 Q21F480 Q32F670 Q31F620 Q31F630 Q22F490 R03F090 Q28F570 Q35F760 Q29F580 Q29F590 Q33F720 Q34F730 Q34F740 Q32F680 Q33F690 Q50F210 Q33F700 Q35F770 Q35F790 Q36F810 Q41F900 R01F010 R010F020 R01F030 Q41F920 Q40F880 Q41F910 Q48F090 R06F140 Q42F940 Q43F950 Q48F100 Q43F960 Q45F990 Q47F070 Q49F140 Q49F150 Q50F220 Q52F300 R03F080 Q51F280 Q52F290 R07F200 Q50F230 Q50F240 Q51F260 Q51F270 Q52F310 Q53F330 R02F060 R09F270 R10F300 R10F340 R11F350 R12F370 Class III Evicel and Evithrom, manufactured with a processing deviation that potentially led to decreased potency, were distributed. 120 B-1048-13
Thrombin, Topical (Human) Evithrom Rx only Distributor: Johnson & Johnson Wound Management A division of Ethicon, Inc. Manufacturer: Omrix Biopharmaceuticals Ltd. 2 mL - NDC 63713-460-02 5 mL- NDC 63713-460-05 Evithrom 2mL Product Code S4602, Lot Number Q36T62K; Product Code 4602, Lot Numbers P49T05K, Q11T44J, Q2T46K, Q45T77J; Evithrom 5 mL Product Code 4605 Lot Numbers P46T84J, P50T150, Q07T23J, Q08T28K, Q23T88K, Q25T93J, Q25T94J, Q27T08J, Q30T31J, Q31T34J, Q31T360, Q32T41K, Q33T48J Class III Evicel and Evithrom, manufactured with a processing deviation that potentially led to decreased potency, were distributed. 18 B-1049-13