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U.S. Department of Health and Human Services

Enforcement Report - Week of February 27, 2013

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Product Detail

Product Description Vascular Graft
Recall Number B-0768-13
Classification Class II
Code Info 9887377; 9887385; 9887396; 9887480
Product Distributed Qty 4
Reason For Recall Human Tissues, recovered from a donor whose donor eligibility determination did not identify if the donor was free from risk factors for and clinical evidence of, infection due to relevant communicable disease agents, were distributed.

Event Detail

Event Id 64210
Product Type Biologics
Status Terminated
Recalling Firm CryoLife, Inc.
City Kennesaw
State GA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-12-12
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Tennessee; Missouri; Kentucky; Texas