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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 Vascular Graft
Recall Number B-1751-13
Classification Class III
Code Info 9832390; 9832483; 9840388
Product Distributed Qty 3 allografts
Reason For Recall Vascular grafts, 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.

Event Detail

Event Id 65235
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 California; Texas
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