FDA Recall
Terminated
Pulmonary heart valve allograft, human tissue for transplantation.
Recall: Z-0525-03
·
Initiated December 19, 2002
Recall
- Recall Number
- Z-0525-03
- Event Number
- 25449
- Firm
- LifeNet
- FEI Number
- 1000512996
- Product Code
- MIE
- Status
- Terminated
- Root Cause
- Other
- Initiated
- December 19, 2002
- Posted
- February 1, 2003
- Terminated
- January 27, 2003
- Address
- 5809 Ward Ct, Virginia Beach, VA, 23455
Description
Pulmonary heart valve allograft, human tissue for transplantation.
Reason
Recalling firm distributed a heart valve from donor whose sera was found potentially positive for Hepatitis C.
Action
Firm notified consignee by phone and letter 12/19/02 and requested valve to be returned.
Distribution
Product was shipped to one hospital in NY
Quantity
1 valve