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U.S. Department of Health and Human Services

Enforcement Report - Week of August 7, 2013

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Event Detail

Event ID 65026
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 2013-03-11
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Florida

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Platelets Pooled Leukocytes Reduced W036812837810; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. 1 B-1764-13
Fresh Frozen Plasma (Apheresis) 2452490; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. 1 B-1765-13
Cryoprecipitated AHF 2055025; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. 1 B-1766-13
Red Blood Cells W036812491773; W036810005930; 2452490; 2055025; 2009327; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. 5 B-1767-13
Platelets 2009327; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. 1 B-1768-13
Blood and Blood Products for Reprocessing W036812491773; W036810005930; 2055025; 2009327; Class III Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. 4 B-1769-13
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