Pulmonary Valve & Conduit
FDA Recall Z-0860-05 · Posted 2005-06-01
Recalling FirmCryolife Inc
Recall StatusTerminated
Product CodeMIE
Date Initiated2005-05-17
Date Terminated2005-06-01
Product Quantity1 unit
Reason for Recall
Subsequent to tissue release, CryoLife received new information related to the donor time of death, which caused the donor to no longer meet CryoLife's acceptance criteria for warm ischemic time.
Firm Action
Consignees were notified by telephone on May 17, 2005. Both tissues were returned and destroyed.
Root Cause
Other
Distribution Pattern
IL, MT
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.