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U.S. Department of Health and Human Services

Enforcement Report - Week of July 10, 2013

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Event Detail

Event ID 64612
Product Type Biologics
Status Terminated
Recalling Firm Blood Assurance Inc
City Chattanooga
State TN
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-02-20
Initial Firm Notification of
Consignee or Public
FAX
Distribution Pattern TN, NY

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Red Blood Cells Leukocytes Reduced P67796 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. 1 unit B-1508-13
Blood and Blood Products for Reprocessing P67796 Class III Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. 1 unit B-1509-13
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