Date Initiated by Firm |
December 19, 2002 |
Date Posted |
February 01, 2003 |
Recall Status1 |
Terminated 3 on January 27, 2003 |
Recall Number |
Z-0525-03 |
Recall Event ID |
25449 |
Product Classification |
Heart-Valve, Allograft - Product Code MIE
|
Product |
Pulmonary heart valve allograft, human tissue for transplantation. |
Code Information |
01-0293HV-02 |
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 |
Action |
Firm notified consignee by phone and letter 12/19/02 and requested valve to be returned. |
Quantity in Commerce |
1 valve |
Distribution |
Product was shipped to one hospital in NY |
Total Product Life Cycle |
TPLC Device Report
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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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