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U.S. Department of Health and Human Services

Enforcement Report - Week of May 15, 2013

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Event Detail

Event ID 64677
Product Type Biologics
Status Terminated
Recalling Firm International Biologics LLC
City Scottsdale
State AZ
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-03-12
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nevada; Ohio; Texas

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Bone IBM1259119006; IBM1259119007; IBM1259119008; IBM1259119009; IBM1259119010; IBM1259119011; IBM1259119012; IBM1259119013; IBM1259119014; IBM1259119015; IBM1259119016; IBM1259119017; IBM1259119018; IBM1259119019; IBM1259119020 Class III Human tissue allografts were processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P. 15 allografts B-1430-13