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U.S. Department of Health and Human Services

Enforcement Report - Week of December 19, 2012

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Event Detail

Event ID 63324
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 2012-09-18
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
Red Blood Cells Leukocytes Reduced Irradiated W036810133837; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. 1 B-0140-13
Fresh Frozen Plasma W036810133837; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. 1 B-0139-13
Platelets Pooled Leukocytes Reduced Irradiated W036810810072; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. 1 B-0138-13
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