CryoValve, Pulmonary Valve & Conduit SG
FDA device recall Z-0019-04 · posted 2003-10-15 · Terminated
Recall details
- Recalling firm
- Cryolife Inc
- Reason for recall
- The heart valve procurement exceeded the warm ischemic time criteria.
- Action taken
- The physician was notified by letter on 8/18/2002. The tissue was reported implanted on 4/08/2003.
- Root cause
- Other
- Status
- Terminated
- Product code
- MIE
- Quantity affected
- 1 unit
- Distribution
- Tissue was distributed to one physician in CA.
- Date initiated
- 2003-08-18
- Date posted
- 2003-10-15
- Date terminated
- 2003-10-15
- Location
- Kennesaw, GA
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