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U.S. Department of Health and Human Services

Enforcement Report - Week of April 17, 2013

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Product Detail

Product Description Heart Valve
Recall Number B-1365-13
Classification Class III
Code Info 10045270
Product Distributed Qty 1
Reason For Recall Human tissue allograft, recovered from a donor whose donor eligibility determination did not confirm the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseeases, was distributed.

Event Detail

Event Id 64660
Product Type Biologics
Status Terminated
Recalling Firm CryoLife, Inc.
City Kennesaw
State GA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-03-18
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Germany, Federal Republic of