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U.S. Department of Health and Human Services

Enforcement Report - Week of January 30, 2013

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Event Detail

Event ID 63570
Product Type Biologics
Status Terminated
Recalling Firm Blood Assurance Inc
City Chattanooga
State TN
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-10-11
Initial Firm Notification of
Consignee or Public
FAX
Distribution Pattern Tennessee; Indiana

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Blood and Blood Products for Reprocessing W043212025175; Class III Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. 1 unit B-0395-13
Red Blood Cells Leukocytes Reduced W043212025175; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. 1 unit B-0394-13
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