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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 65238
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 Michigan; Maryland; Texas; Minnesota

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Vascular Graft 10022449; 10022514; 10022551 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, were distributed. 3 units B-1988-13
Heart Valve 10022483 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, were distributed. 1 unit B-1989-13
Cardiac Tissue, Non-valved 10022525 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, were distributed. 1 unit B-1990-13
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