CryoValve, Synegraft Pulmonary Valve & Conduit
FDA device recall Z-1038-03 · posted 2003-07-22 · Terminated
Recall details
- Recalling firm
- Cryolife Inc
- Reason for recall
- Human tissue for transplantation, which was associated with a donor whose pre-processing culture detected microorganisms, was distributed.
- Action taken
- The physician was notified by letter on 7/10/2003.
- Root cause
- Other
- Status
- Terminated
- Product code
- MIE
- Quantity affected
- 1 tissue
- Distribution
- The tissue was distributed to one physician in CA.
- Date initiated
- 2003-07-10
- Date posted
- 2003-07-22
- Date terminated
- 2004-05-12
- Location
- Kennesaw, GA
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