ClearanceBrief
Recall Z-0775-04 ยท MIE Heart-Valve, Allograft

Cryolife Inc

CryoValve, Aortic Valve & Conduit

DateJul 20, 2004 (initiated Mar 24, 2004)
StatusTerminated
ReasonThe donor of the tissue had a viral syndrome at the time of death.
Root causeOther
ActionConsignees were notified by letter on 3/24/2004.
Quantity1 unit
DistributionCT, PA
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.