Vaccines, Blood & Biologics
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Important Product Information – Evicel and Evithrom
DATE NOTIFICATION INITIATED: September 26, 2012
Evicel® Product Codes | Product Description | Lot Numbers |
|---|---|---|
S3905 | FIBRIN SEALANT (HUMAN) EVICEL* - 5mL Sample | Q02F010 |
S3905 | FIBRIN SEALANT (HUMAN) EVICEL* - 5mL Sample | Q05F120 |
S3905 | FIBRIN SEALANT (HUMAN) EVICEL* - 5mL Sample | Q19F420 |
S3905 | FIBRIN SEALANT (HUMAN) EVICEL* - 5mL Sample | Q35F780 |
S3905 | FIBRIN SEALANT (HUMAN) EVICEL* - 5mL Sample | Q33F700 |
3901 | FIBRIN SEALANT (HUMAN) EVICEL* -1 mL | Q44F97K |
3901 | FIBRIN SEALANT (HUMAN) EVICEL* -1 mL | Q53F350 |
3902 | FIBRIN SEALANT (HUMAN) EVICEL* -2 mL | Q03F030 |
3902 | FIBRIN SEALANT (HUMAN) EVICEL* -2 mL | Q09F310 |
3902 | FIBRIN SEALANT (HUMAN) EVICEL* -2 mL | Q29F610 |
3902 | FIBRIN SEALANT (HUMAN) EVICEL* -2 mL | Q44F980 |
3902 | FIBRIN SEALANT (HUMAN) EVICEL* -2 mL | Q31F640 |
3902 | FIBRIN SEALANT (HUMAN) EVICEL* -2 mL | Q35F750 |
3902 | FIBRIN SEALANT (HUMAN) EVICEL* -2 mL | Q36F820 |
3902 | FIBRIN SEALANT (HUMAN) EVICEL* -2 mL | Q46F040 |
3902 | FIBRIN SEALANT (HUMAN) EVICEL* -2 mL | Q47F050 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | P44F050 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | P45F100 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | P45F090 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | P46F120 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | P48F180 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | R06F130 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | R07F180 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | R07F190 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | R07F250 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | R07F260 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | R10F310 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | R10F320 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | R10F330 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | R12F380 |
Evicel® Product Codes | Product Description | Lot Numbers |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | P48F190 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | P53F390 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q03F040 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | P50F310 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | P50F330 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q02F010 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | P52F370 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q11F320 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | P52F360 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q02F020 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q04F090 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q04F100 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q04F110 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q05F120 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q32F660 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q05F130 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q05F140 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q06F160 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q06F170 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q07F210 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q08F280 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q08F290 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q16F400 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q08F300 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q13F340 |
Evicel® Product Codes | Product Description | Lot Numbers |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q33F710 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q13F350 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q14F360 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q14F370 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q15F380 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q15F390 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q19F410 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q28F560 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q19F420 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q21F470 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q21F480 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q32F670 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q31F620 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q31F630 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q22F490 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | R03F090 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q28F570 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q35F760 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q29F580 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q29F590 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q33F720 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q34F730 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q34F740 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q32F680 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q33F690 |
Evicel® Product Codes | Product Description | Lot Numbers |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q50F210 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q33F700 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q35F770 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q35F790 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q36F810 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q41F900 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | R01F010 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | R01F020 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | R01F030 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q41F920 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q40F880 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q41F910 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q48F090 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | R06F140 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q42F940 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q43F950 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q48F100 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q43F960 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q45F990 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q47F070 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q49F140 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q49F150 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q50F220 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q52F300 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | R03F080 |
Evicel® Product Codes | Product Description | Lot Numbers |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q51F280 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q52F290 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | R07F200 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q50F230 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q50F240 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q51F260 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q51F270 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q52F310 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | Q53F330 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | R02F060 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | R09F270 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | R10F300 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | R10F340 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | R11F350 |
3905 | FIBRIN SEALANT (HUMAN) EVICEL*-5 mL | R12F370 |
EVITHROM® Product Codes | Product Description | Lot Numbers |
S4602 | THROMBIN TOPICAL (HUMAN) EVITHROM*- 2mL Sample | Q36T62K |
4602 | THROMBIN TOPICAL (HUMAN) EVITHROM*- 2mL | P49T05K |
4602 | THROMBIN TOPICAL (HUMAN) EVITHROM*- 2mL | Q11T44J |
4602 | THROMBIN TOPICAL (HUMAN) EVITHROM*- 2mL | Q32T46K |
4602 | THROMBIN TOPICAL (HUMAN) EVITHROM*- 2mL | Q45T77J |
4605 | THROMBIN TOPICAL (HUMAN) EVITHROM* - 5mL | P46T84J |
4605 | THROMBIN TOPICAL (HUMAN) EVITHROM* - 5mL | P50T150 |
4605 | THROMBIN TOPICAL (HUMAN) EVITHROM* - 5mL | Q07T23J |
4605 | THROMBIN TOPICAL (HUMAN) EVITHROM* - 5mL | Q08T28K |
4605 | THROMBIN TOPICAL (HUMAN) EVITHROM* - 5mL | Q23T88K |
4605 | THROMBIN TOPICAL (HUMAN) EVITHROM* - 5mL | Q25T93J |
4605 | THROMBIN TOPICAL (HUMAN) EVITHROM* - 5mL | Q25T94J |
4605 | THROMBIN TOPICAL (HUMAN) EVITHROM* - 5mL | Q27T08J |
4605 | THROMBIN TOPICAL (HUMAN) EVITHROM* - 5mL | Q30T31J |
4605 | THROMBIN TOPICAL (HUMAN) EVITHROM* - 5mL | Q31T34J |
4605 | THROMBIN TOPICAL (HUMAN) EVITHROM* - 5mL | Q31T360 |
4605 | THROMBIN TOPICAL (HUMAN) EVITHROM* - 5mL | Q32T41K |
4605 | THROMBIN TOPICAL (HUMAN) EVITHROM* - 5mL | Q33T48J |
MANUFACTURER:
OMRIX biopharmaceuticals, Ltd.
Israel
REASON:
Ethicon, Inc. is notifying customers of a manufacturing process deviation that may have potentially led to the production of vials of Thrombin with decreased potency. This manufacturing deviation may affect product that was produced before December 25, 2011, and was discovered through an internal review of the manufacturing process. We believe this potential decrease in potency does not pose a risk to patients as the Thrombin level would still be effective in clot formation. Ethicon has not received any reports of adverse events related to this issue. Customers are asked to return product in inventory that corresponds to the lot numbers and code numbers listed.
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The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.
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