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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 64429
Product Type Biologics
Status Terminated
Recalling Firm Community Blood Centers of South Florida, Inc.
City Hialeah
State FL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-01-30
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Switzerland; Florida; New York

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Blood and Blood Products for Reprocessing 2351667; 9671521; 9638986; 9458747; Class III Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. 4 B-1414-13
Red Blood Cells 2615454; 2536100; 2351667; 1791712; 1692582; 1699599; 9671521; 9458747; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. 8 B-1413-13
Platelets 1791712; 9671521; 9638986; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. 3 B-1412-13
Red Blood Cells (Apheresis) Leukocytes Reduced W036810024856; W036810024856; W036808146279; W036808146279; 2084027; 2084027; 9638986; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. 7 B-1411-13
Fresh Frozen Plasma 2615454; 2536100; 1791712; 1692582; 1699599; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. 5 B-1410-13
Platelets Pooled Leukocytes Reduced 2935922; 2917309; 2906733; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. 3 B-1409-13
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