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U.S. Department of Health and Human Services

Enforcement Report - Week of July 31, 2013

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Event Detail

Event ID 65055
Product Type Biologics
Status Terminated
Recalling Firm HCSC-Blood Center
City Bethlehem
State PA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-01-04
Initial Firm Notification of
Consignee or Public
FAX
Distribution Pattern Pennsylvania; Korea,

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Blood and Blood Products for Reprocessing W050912009111; W050912002027; W05091009851; W050912000741; Class III Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. 4 B-1819-13
Red Blood Cells Leukocytes Reduced W050912009111; W050912000741; Class II Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. 2 B-1818-13
Red Blood Cells W050912002027; W050912009851; Class II Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. 2 units B-1817-13
Red Blood Cells Irradiated W050912008713; Class II Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. 1 B-1816-13
Fresh Frozen Plasma (Apheresis) W050912005453; Class II Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. 1 B-1815-13
Red Blood Cells (Apheresis) W050912005453; Class II Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. 1 B-1814-13
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