CryoValve Allograft, Heart valve
FDA device recall Z-0866-03 · posted 2003-05-22 · Terminated
Recall details
- Recalling firm
- Cryolife Inc
- Reason for recall
- Microorganisms were detected in associated allografts.
- Action taken
- Implanting physicians were notified via letter on April 30, 2003. They were advised to quarantine and return the allograft if not implanted. A self addressed, stamped postcard was included to affirm receipt of the notice and to provide information of final disposition of the allograft.
- Root cause
- Other
- Status
- Terminated
- Product code
- MIE
- Quantity affected
- 8 units
- Distribution
- The components were distributed to hospitals and physicians located in CA, IL IN, , NM, OH and OK.
- Date initiated
- 2003-04-30
- Date posted
- 2003-05-22
- Date terminated
- 2004-04-29
- Location
- Kennesaw, GA
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