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U.S. Department of Health and Human Services

Enforcement Report - Week of January 16, 2013

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Event Detail

Event ID 63327
Product Type Biologics
Status Terminated
Recalling Firm Community Blood Centers of Florida, Inc.
City Lauderhill
State FL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-08-17
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Tennessee; Switzerland; Florida

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Cryoprecipitated AHF, Pooled W036811822350; Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. 1 B-0275-13
Fresh Frozen Plasma 2243062; Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. 1 B-0276-13
Cryoprecipitated AHF W036809216741; 2479070; Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. 2 B-0277-13
Platelets Pooled Leukocytes Reduced W036810821967; W036809821585; W036809813222; 2911209; Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. 4 B-0278-13
Blood and Blood Products for Reprocessing W036811262717; W036810243696; W036810039414; W036809359200; W036809216741; 2479070; Class III Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. 6 B-0279-13
Red Blood Cells W036811262717; W036810039414; W036809359200; W036809216741; 2243062; 2479070; W036810243696; Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. 7 B-0280-13
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