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U.S. Department of Health and Human Services

Enforcement Report - Week of November 14, 2012

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Event Detail

Event ID 62819
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 2012-03-22
Initial Firm Notification of
Consignee or Public
Telephone
Distribution Pattern Pennsylvania; Florida; New York

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Cryoprecipitated AHF W036810147118; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. 1 unit B-2476-12
Blood and Blood Products for Reprocessing W036810147118; Class III Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. 1 unit B-2475-12
Platelets Pooled Leukocytes Reduced W036810810933; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. 1 unit B-2474-12
Red Blood Cells W036810147118; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. 1 unit B-2473-12
Red Blood Cells (Apheresis) Leukocytes Reduced W036811167601(Part A); W036811167601(Part B) Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. 2 units B-2472-12
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