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U.S. Department of Health and Human Services

Enforcement Report - Week of November 7, 2012

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Event Detail

Event ID 62544
Product Type Biologics
Status Terminated
Recalling Firm Blood Assurance Inc
City Chattanooga
State TN
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-06-19
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
Red Blood Cells Leukocytes Reduced W043211089405; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. 1 B-2420-12
Platelets Pheresis Leukocytes Reduced W043211094597; W043211094505; W043211089446; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. 3 B-2419-12
Platelets Pheresis Leukocytes Reduced Irradiated W043211094597; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. 1 B-2418-12
Blood and Blood Products for Reprocessing W043211089405; Class III Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. 1 B-2421-12
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