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U.S. Department of Health and Human Services

Enforcement Report - Week of September 12, 2012

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Event Detail

Event ID 39858
Product Type Biologics
Status Terminated
Recalling Firm Biomat USA, Inc.
City Los Angeles
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2005-03-08
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern all units were shipped to Spain

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Source Plasma 380001943, 380002525, 380004157, 380005454, 380006271, 380007553, 380007713, 380002110. 380001521, 380003365, 380003625, 380005713, 380006093, 380008037, 380008629, 380008896, 380009446, 380009942, 380010141, 380010432, 380010668, 380011122, 380011476, 380012030, 380012185, 380012470, 380012689, 380013021, 380013200, 380013643, 380013915, 380014838, 380015927, 380016011, 380016486. Class III Blood products, collected from a donor, whose suitability to donate was not adequately determined, were distributed 35 units B-2370-12
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