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U.S. Department of Health and Human Services

Enforcement Report - Week of August 28, 2013

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Event Detail

Event ID 65276
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 2013-04-26
Initial Firm Notification of
Consignee or Public
Telephone
Distribution Pattern Switzerland, FL, NY

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Platelets Irradiated 2030388 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. 1 unit B-2134-13
Platelets 2236855 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. 1 unit B-2135-13
Platelets Pooled Leukocytes Reduced Irradiated W036809820065 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. 1 unit B-2136-13
Cryoprecipitated AHF 2236855; W036809257757 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. 2 units B-2137-13
Red Blood Cells Leukocytes Reduced W036809257757 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. 1 unit B-2138-13
Platelets Pooled Leukocytes Reduced W036810808509 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. 1 unit B-2139-13
Red Blood Cells 2030388; 2236855; 2326541; W036809346298; W036810169486; W036810134483 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. 6 units B-2140-13
Blood and Blood Products for Reprocessing W036809257757; W036809346298; W036810134483 Class III Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. 3 units B-2141-13
Fresh Frozen Plasma 2030388; 2326541; W036810271097 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. 3 units B-2142-13
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