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U.S. Department of Health and Human Services

Enforcement Report - Week of January 2, 2013
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Event Detail

Event ID 53064
Product Type Biologics
Status Terminated
Recalling Firm Bio-Medics
City Provo
State UT
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2008-06-11
Initial Firm Notification of
Consignee or Public		 FAX
Distribution Pattern Austria

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Source Plasma 8120001398, 8120001495, 8120001622, 8120001725, 8120001873, 8120001954, 8120002241, 8120002291, 8120002471, 8120002534, 8120002726, 8120002806, 8120003353, 8120003445, 8120003582, 8120003690, 8120003794, 8120003905, 8120004027, 8120004135, 8120004270, 8120004451, 8120004540, 8120004655, 8120004758, 8120004888, 8120004971 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. 27 units B-0308-13
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