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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 62743
Product Type Biologics
Status Terminated
Recalling Firm Blood Assurance Inc
City Chattanooga
State TN
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-06-20
Initial Firm Notification of
Consignee or Public
FAX
Distribution Pattern South Carolina; New York; Indiana

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Recovered Plasma W043211038237; W043210095642; Class III 2 B-2484-12
Red Blood Cells Leukocytes Reduced W043211038237; W043210095642; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed 2 B-2483-12
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