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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
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
Platelets 2009327; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. 1 B-1768-13
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
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
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
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
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