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U.S. Department of Health and Human Services

Enforcement Report - Week of May 8, 2013

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Event Detail

Event ID 64169
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 2013-01-10
Initial Firm Notification of
Consignee or Public
Telephone
Distribution Pattern Switzerland; Florida

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Red Blood Cells W036810087981; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. 1 B-1074-13
Cryoprecipitated AHF W036810087981; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. 1 B-1075-13
Blood and Blood Products for Reprocessing W036810087981; Class III Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. 1 B-1076-13
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