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U.S. Department of Health and Human Services

Enforcement Report - Week of March 20, 2013

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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
Distribution Pattern Colorado

Product Detail

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