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U.S. Department of Health and Human Services

Enforcement Report - Week of September 26, 2012

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Event Detail

Event ID 62354
Product Type Biologics
Status Terminated
Recalling Firm Blood Assurance Inc
City Chattanooga
State TN
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-05-07
Initial Firm Notification of
Consignee or Public
FAX
Distribution Pattern Tennessee, Georgia, Indiana

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Recovered Plasma W043211081628 Class III Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. 1 unit B-2137-12
Red Blood Cells Leukocytes Reduced W043211081628 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. 1 unit B-2136-12
Platelets Pheresis Leukocytes Reduced W043212033535 (2 units) Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. 2 units B-2135-12
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