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U.S. Department of Health and Human Services

Enforcement Report - Week of April 24, 2013

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Event Detail

Event ID 64050
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 2012-12-06
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Michigan; Florida

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Red Blood Cells (Apheresis) Leukocytes Reduced 2192852; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. 1 unit B-1002-13
Platelets Irradiated 2192852; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. 1 unit B-1001-13
Fresh Frozen Plasma 2192852; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. 1 unit B-1000-13
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