Aortic Valve & Conduit
FDA device recall Z-0859-05 · posted 2005-06-01 · Terminated
Recall details
- Recalling firm
- Cryolife Inc
- 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.
- Action taken
- Consignees were notified by telephone on May 17, 2005. Both tissues were returned and destroyed.
- Root cause
- Other
- Status
- Terminated
- Product code
- MIE
- Quantity affected
- 1 unit
- Distribution
- IL, MT
- Date initiated
- 2005-05-17
- Date posted
- 2005-06-01
- Date terminated
- 2005-06-01
- Location
- Kennesaw, GA
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