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U.S. Department of Health and Human Services

Enforcement Report - Week of November 21, 2012

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Product Detail

Product Description Amniotic membrane
Recall Number B-0194-13
Classification Class II
Code Info 2012838004; 2012838005; 2012838006; 2012838007; 2012838008; 2012838009; 2012838010; 2012838011; 2012838012; 2012838013; 2012838014; 2012838015; 2012838016; 2012838017; 2012838018; 2012838019; 2012838020; 2012838021;
Product Distributed Qty 18
Reason For Recall Amniotic membrane allografts, recovered from a donor whose preprocessing tissue culture indicated growth of Group D Enterococcus, were distributed.

Event Detail

Event Id 63348
Product Type Biologics
Status Terminated
Recalling Firm Surgical Biologics LLC
City Kennesaw
State GA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-07-20
Initial Firm Notification of Consignee or Public Telephone
Distribution Pattern Louisiana
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