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U.S. Department of Health and Human Services

Enforcement Report - Week of August 15, 2012
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Event Detail

Event ID 61994
Product Type Biologics
Status Terminated
Recalling Firm Blood Assurance Inc
City Chattanooga
State TN
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-05-08
Initial Firm Notification of
Consignee or Public		 FAX
Distribution Pattern GA, IN

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Red Blood Cells Leukocytes Reduced W043211081138 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. 1 unit B-2038-12
Blood and Blood Products for Reprocessing W043211081138 Class III Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. 1 unit B-2039-12
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