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U.S. Department of Health and Human Services

Enforcement Report - Week of February 27, 2013

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Event Detail

Event ID 64210
Product Type Biologics
Status Terminated
Recalling Firm CryoLife, Inc.
City Kennesaw
State GA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-12-12
Initial Firm Notification of
Consignee or Public
Distribution Pattern Tennessee; Missouri; Kentucky; Texas

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Vascular Graft 9887377; 9887385; 9887396; 9887480 Class II Human Tissues, recovered from a donor whose donor eligibility determination did not identify if the donor was free from risk factors for and clinical evidence of, infection due to relevant communicable disease agents, were distributed. 4 B-0768-13