CryoValve, Pulmonary Valve and Conduit
FDA device recall Z-0684-05 · posted 2005-04-06 · Terminated
Recall details
- Recalling firm
- Cryolife Inc
- Reason for recall
- During a retrospective review, CryoLife noted that the donor tissue exceeded the acceptable warm ischemic time when utilizing the 'Last Seen Alive' time in their calculation.
- Action taken
- Consignees were notified by letters dated 12/17/2004, 01/03/2005 and 01/19/2005.
- Root cause
- Other
- Status
- Terminated
- Product code
- MIE
- Quantity affected
- 1 tissue
- Distribution
- CA, NJ, TX
- Date initiated
- 2004-12-17
- Date posted
- 2005-04-06
- Date terminated
- 2005-06-01
- Location
- Kennesaw, GA
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