Vaccines, Blood & Biologics

Important Product Information – Evicel and Evithrom

DATE NOTIFICATION INITIATED: September 26, 2012

Evicel Product CodesProduct DescriptionLot Numbers
S3905FIBRIN SEALANT (HUMAN) EVICEL* - 5mL SampleQ02F010
S3905FIBRIN SEALANT (HUMAN) EVICEL* - 5mL SampleQ05F120
S3905FIBRIN SEALANT (HUMAN) EVICEL* - 5mL SampleQ19F420
S3905FIBRIN SEALANT (HUMAN) EVICEL* - 5mL SampleQ35F780
S3905FIBRIN SEALANT (HUMAN) EVICEL* - 5mL SampleQ33F700
3901FIBRIN SEALANT (HUMAN) EVICEL* -1 mLQ44F97K
3901FIBRIN SEALANT (HUMAN) EVICEL* -1 mLQ53F350
3902FIBRIN SEALANT (HUMAN) EVICEL* -2 mLQ03F030
3902FIBRIN SEALANT (HUMAN) EVICEL* -2 mLQ09F310
3902FIBRIN SEALANT (HUMAN) EVICEL* -2 mLQ29F610
3902FIBRIN SEALANT (HUMAN) EVICEL* -2 mLQ44F980
3902FIBRIN SEALANT (HUMAN) EVICEL* -2 mLQ31F640
3902FIBRIN SEALANT (HUMAN) EVICEL* -2 mLQ35F750
3902FIBRIN SEALANT (HUMAN) EVICEL* -2 mLQ36F820
3902FIBRIN SEALANT (HUMAN) EVICEL* -2 mLQ46F040
3902FIBRIN SEALANT (HUMAN) EVICEL* -2 mLQ47F050
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLP44F050
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLP45F100
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLP45F090
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLP46F120
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLP48F180
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLR06F130
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLR07F180
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLR07F190
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLR07F250
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLR07F260
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLR10F310
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLR10F320
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLR10F330
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLR12F380
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLP48F190
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLP53F390
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ03F040
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLP50F310
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLP50F330
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ02F010
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLP52F370
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ11F320
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLP52F360
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ02F020
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ04F090
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ04F100
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ04F110
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ05F120
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ32F660
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ05F130
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ05F140
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ06F160
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ06F170
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ07F210
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ08F280
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ08F290
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ16F400
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ08F300
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ13F340
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ33F710
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ13F350
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ14F360
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ14F370
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ15F380
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ15F390
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ19F410
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ28F560
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ19F420
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ21F470
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ21F480
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ32F670
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ31F620
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ31F630
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ22F490
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLR03F090
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ28F570
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ35F760
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ29F580
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ29F590
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ33F720
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ34F730
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ34F740
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ32F680
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ33F690
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ50F210
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ33F700
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ35F770
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ35F790
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ36F810
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ41F900
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLR01F010
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLR01F020
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLR01F030
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ41F920
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ40F880
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ41F910
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ48F090
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLR06F140
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ42F940
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ43F950
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ48F100
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ43F960
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ45F990
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ47F070
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ49F140
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ49F150
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ50F220
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ52F300
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLR03F080
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ51F280
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ52F290
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLR07F200
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ50F230
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ50F240
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ51F260
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ51F270
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ52F310
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLQ53F330
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLR02F060
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLR09F270
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLR10F300
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLR10F340
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLR11F350
3905FIBRIN SEALANT (HUMAN) EVICEL*-5 mLR12F370
EVITHROM Product CodesProduct DescriptionLot Numbers
S4602THROMBIN TOPICAL (HUMAN) EVITHROM*- 2mL SampleQ36T62K
4602THROMBIN TOPICAL (HUMAN) EVITHROM*- 2mLP49T05K
4602THROMBIN TOPICAL (HUMAN) EVITHROM*- 2mLQ11T44J
4602THROMBIN TOPICAL (HUMAN) EVITHROM*- 2mLQ32T46K
4602THROMBIN TOPICAL (HUMAN) EVITHROM*- 2mLQ45T77J
4605THROMBIN TOPICAL (HUMAN) EVITHROM* - 5mLP46T84J
4605THROMBIN TOPICAL (HUMAN) EVITHROM* - 5mLP50T150
4605THROMBIN TOPICAL (HUMAN) EVITHROM* - 5mLQ07T23J
4605THROMBIN TOPICAL (HUMAN) EVITHROM* - 5mLQ08T28K
4605THROMBIN TOPICAL (HUMAN) EVITHROM* - 5mLQ23T88K
4605THROMBIN TOPICAL (HUMAN) EVITHROM* - 5mLQ25T93J
4605THROMBIN TOPICAL (HUMAN) EVITHROM* - 5mLQ25T94J
4605THROMBIN TOPICAL (HUMAN) EVITHROM* - 5mLQ27T08J
4605THROMBIN TOPICAL (HUMAN) EVITHROM* - 5mLQ30T31J
4605THROMBIN TOPICAL (HUMAN) EVITHROM* - 5mLQ31T34J
4605THROMBIN TOPICAL (HUMAN) EVITHROM* - 5mLQ31T360
4605THROMBIN TOPICAL (HUMAN) EVITHROM* - 5mLQ32T41K
4605THROMBIN TOPICAL (HUMAN) EVITHROM* - 5mLQ33T48J

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.


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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