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U.S. Department of Health and Human Services

Enforcement Report - Week of December 5, 2012

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Event Detail

Event ID 47971
Product Type Biologics
Status Terminated
Recalling Firm BioLife Plasma Services L.P.
City Ogden
State UT
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2008-03-07
Initial Firm Notification of
Consignee or Public
Distribution Pattern CA

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Source Plasma 07OUTE7481; 07OUTE6595; 07OUTE5995; 07OUTE5440; 07OUTE3268; 07OUTE2865; 07OUTE1483; 07OUTE1041; 07OUTD9210; 07OUTD8745; 07OUTD8184; 07OUTD7577; 07OUTD6988; 07OUTD6075; 07OUTD5854; 07OUTD0584; 07OUTC7070; 07OUTC6440; 07OUTC1645; 07OUTC2199; 07OUTC3461; 07OUTC3772; 07OUTC4978; 07OUTC5334; 07OUTC5999 Class II Blood products, which were collected from a donor in which donor suitability were not adequately determined, were distributed. 25 units B-0088-13