CryoValve Allograft, Pulmonary Heart valve & Conduit.
FDA device recall Z-0861-03 · posted 2003-05-22 · Terminated
Recall details
- Recalling firm
- Cryolife Inc
- Reason for recall
- Microorganisms were detected in associated allografts after initial release of donor.
- Action taken
- The implanting physician was notified via letter on May 5, 2003. Allograft was reported implanted 1/17/2003.
- Root cause
- Other
- Status
- Terminated
- Product code
- MIE
- Quantity affected
- 1 unit
- Distribution
- Allograft was distributed to and implanted by one physician in California.
- Date initiated
- 2003-05-05
- Date posted
- 2003-05-22
- Date terminated
- 2003-07-17
- Location
- Kennesaw, GA
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