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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmDecember 19, 2002
Date PostedFebruary 01, 2003
Recall Status1 Terminated 3 on January 27, 2003
Recall NumberZ-0525-03
Recall Event ID 25449
Product Classification Heart-Valve, Allograft - Product Code MIE
ProductPulmonary heart valve allograft, human tissue for transplantation.
Code Information 01-0293HV-02
FEI Number 1000512996
Recalling Firm/
Manufacturer		 LifeNet
5809 Ward Ct
Virginia Beach VA 23455
Manufacturer Reason
for Recall		Recalling firm distributed a heart valve from donor whose sera was found potentially positive for Hepatitis C.
FDA Determined
Cause 2		Other
ActionFirm notified consignee by phone and letter 12/19/02 and requested valve to be returned.
Quantity in Commerce1 valve
DistributionProduct was shipped to one hospital in NY
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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