ClearanceBrief
Recall Z-0686-05 ยท MIE Heart-Valve, Allograft

Cryolife Inc

CryoValve, Aortic Valve and Conduit

DateApr 6, 2005 (initiated Dec 2, 2004)
StatusTerminated
ReasonAn incorrect lot number was entered in the production record for the solution in which this allograft was packaged.
Root causeOther
ActionConsignee was notified by letter on 12/02/2004.
Quantity1 tissue
DistributionTN
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.