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U.S. Department of Health and Human Services

Enforcement Report - Week of July 24, 2013

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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

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Heart Valve 9962113 Class III 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. 1 unit B-1997-13
Cardiac Tissue, Non-valved 9962099 Class III 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. 1 allograft B-1996-13
Vascular Graft 9962023 Class III 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. 1 allograft B-1995-13
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