ClearanceBrief
Recall Z-0677-03 ยท MIE Heart-Valve, Allograft

DCI Donor Services Tissue Services Division

One heart and pericardium from donor 12144.

DateMar 26, 2003 (initiated Aug 20, 2002)
StatusTerminated
ReasonHuman tissue was procured from donor using non-sterile instruments.
Root causeOther
ActionConsignee was notified by memorandum on 8/20/2002.
QuantityOne heart and pericardium.
DistributionGA
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.