CryoValve, Pulmonary Valve & Conduit
FDA device recall Z-0026-05 · posted 2004-10-20 · Terminated
Recall details
- Recalling firm
- Cryolife Inc
- Reason for recall
- A pre-implant swab culture of the aortic valve, which was procured from the same donor, was positive for Methicillin resistant Staphyococcus aureus.
- Action taken
- The physician was notified by letter on 07/15/2004.
- Root cause
- Other
- Status
- Terminated
- Product code
- MIE
- Quantity affected
- 1 tissue
- Distribution
- The tissue was shipped to one physician in CA.
- Date initiated
- 2004-07-15
- Date posted
- 2004-10-20
- Date terminated
- 2007-12-31
- Location
- Kennesaw, GA
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