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U.S. Department of Health and Human Services

Enforcement Report - Week of June 12, 2013

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Event Detail

Event ID 64484
Product Type Biologics
Status Terminated
Recalling Firm Blood Assurance Inc
City Chattanooga
State TN
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-02-12
Initial Firm Notification of
Consignee or Public
FAX
Distribution Pattern Tennessee

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Plasma Frozen within 24 hours (FP24) W043209019747; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. 1 B-1383-13
Red Blood Cells Leukocytes Reduced W043209019747; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. 1 B-1382-13
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