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U.S. Department of Health and Human Services

Enforcement Report - Week of August 15, 2012

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Event Detail

Event ID 61992
Product Type Biologics
Status Terminated
Recalling Firm Blood Assurance Inc
City Chattanooga
State TN
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-05-01
Initial Firm Notification of
Consignee or Public
FAX
Distribution Pattern TN, GA, NY

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Fresh Frozen Plasma V26698 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. 1 unit B-2015-12
Blood and Blood Products for Reprocessing V89413 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. 1 unit B-2014-12
Plasma Frozen within 24 hours (FP24) W043210075817 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. 1 unit B-2013-12
Red Blood Cells Leukocytes Reduced V89413; V26698; W043210088572; W043210075817 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. 4 units B-2012-12
Cryoprecipitated AHF, Pooled W043210088572 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. 1 unit B-2011-12
Red Blood Cells (Apheresis) Leukocytes Reduced W043211094961-A; W043211094961-B; W043211044082-A; W043211025338-A; W043211044082-B; W043211025338-B Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. 6 units B-2010-12
Plasma Cryoprecipitated Reduced W043210088572 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. 1 unit B-2009-12
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