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U.S. Department of Health and Human Services

Enforcement Report - Week of November 14, 2012

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Event Detail

Event ID 62860
Product Type Biologics
Status Terminated
Recalling Firm Community Blood Centers of South Florida, Inc.
City Hialeah
State FL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-07-10
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Switzerland; Florida

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Blood and Blood Products for Reprocessing W036809230283; Class III Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. 1 unit B-2542-12
Cryoprecipitated AHF W036809230283; Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. 1 unit B-2541-12
Platelets Pooled Leukocytes Reduced W036809807127; Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. 1 unit B-2540-12
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