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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 48247
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 2008-04-17
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 07OUTF1661; 07OUTF2092; 07OUTF3219; 08OUTF2071; 08OUTF4413; 08OUTF5051; 08OUTF5772; 08OUTF6290; 08OUTF6931; 07OUTF4170; 07OUTF4787; 2473; 08OUTF7761; 08OUTF8282 Class III Blood products, which were collected from a donor in which donor suitability were not adequately determined, were distributed. 14 units B-0089-13