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U.S. Department of Health and Human Services

Enforcement Report - Week of August 28, 2013

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Event Detail

Event ID 65221
Product Type Biologics
Status Terminated
Recalling Firm HCSC-Blood Center
City Bethlehem
State PA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-04-10
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Pennsylvania

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Red Blood Cells Leukocytes Reduced W050912006948; Class III Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. 1 B-2107-13
Fresh Frozen Plasma W050912006948; Class III Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. 1 B-2108-13
Platelets Pheresis Leukocytes Reduced Irradiated W050912005655; Class II Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. 1 B-2109-13
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