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U.S. Department of Health and Human Services

Enforcement Report - Week of July 24, 2013

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Product Detail

Product Description Cardiac Tissue, Non-valved
Recall Number B-1996-13
Classification Class III
Code Info 9962099
Product Distributed Qty 1 allograft
Reason For Recall Human tissue allografts, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, was distributed.

Event Detail

Event Id 65234
Product Type Biologics
Status Terminated
Recalling Firm CryoLife, Inc.
City Kennesaw
State GA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-05-17
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern New York; West Virginia; Indiana
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