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U.S. Department of Health and Human Services

Enforcement Report - Week of June 19, 2013

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Product Detail

Product Description Platelets Pheresis Leukocytes Reduced
Recall Number B-1419-13
Classification Class II
Code Info 8814517; 8814559; W038608880648.
Product Distributed Qty 3 units
Reason For Recall Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.

Event Detail

Event Id 49299
Product Type Biologics
Status Terminated
Recalling Firm Suncoast Communities Blood Bank, Inc.
City Sarasota
State FL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2008-06-21
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern FL, MA, TN, NJ, KY, Puerto Rico
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