CryoValve Pulmonary Valve & Conduit.
FDA device recall Z-0938-03 · posted 2003-06-17 · Terminated
Recall details
- Recalling firm
- Cryolife Inc
- Reason for recall
- Microorganisms detected in associated allografts.
- Action taken
- The medical facility was notified by letter on May 23, 2003. The implanting physician was notified by letter on May 28, 2003.
- Root cause
- Other
- Status
- Terminated
- Product code
- MIE
- Quantity affected
- 2 individual heart valve allografts.
- Distribution
- The tissues were distributed to one medical facility in CT and to one physician in MT.
- Date initiated
- 2003-05-23
- Date posted
- 2003-06-17
- Date terminated
- 2003-12-10
- Location
- Kennesaw, GA
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