Recall Z-0525-03 ยท MIE Heart-Valve, Allograft
LifeNet
Pulmonary heart valve allograft, human tissue for transplantation.
| Date | Feb 1, 2003 (initiated Dec 19, 2002) |
| Status | Terminated |
| Reason | Recalling firm distributed a heart valve from donor whose sera was found potentially positive for Hepatitis C. |
| Root cause | Other |
| Action | Firm notified consignee by phone and letter 12/19/02 and requested valve to be returned. |
| Quantity | 1 valve |
| Distribution | Product was shipped to one hospital in NY |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.