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U.S. Department of Health and Human Services

Enforcement Report - Week of August 28, 2013

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Event Detail

Event ID 65437
Product Type Biologics
Status Terminated
Recalling Firm LifeNet Health
City Virginia Beach
State VA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-05-10
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Massachusetts

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Cardiac Tissue, Non-valved 083696HV02 Class II Cardiac pulmonary patch, recovered from a donor and not tested using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, was distributed. 1 allograft B-2097-13
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