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U.S. Department of Health and Human Services

Enforcement Report - Week of October 24, 2012

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Event Detail

Event ID 62741
Product Type Biologics
Status Terminated
Recalling Firm Blood Assurance Inc
City Chattanooga
State TN
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2011-07-13
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
Red Blood Cells Leukocytes Reduced W043210092064; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. 1 B-2480-12
Recovered Plasma W043210092064; Class III Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. 1 B-2481-12
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