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U.S. Department of Health and Human Services

Enforcement Report - Week of March 20, 2013

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Product Detail

Product Description Platelets Pheresis Leukocytes Reduced
Recall Number B-0690-13
Classification Class II
Code Info W056312004293;
Product Distributed Qty 1
Reason For Recall Blood product, with platelet yield that did not meet the specified minimum requirement, was distributed.

Event Detail

Event Id 63860
Product Type Biologics
Status Terminated
Recalling Firm St Mary's Hospital and Medical Center, Inc.
City Grand Junction
State CO
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-08-20
Initial Firm Notification of Consignee or Public E-Mail
Distribution Pattern Colorado