CryoValve, Aortic Valve
FDA device recall Z-0168-05 · posted 2004-11-03 · Terminated
Recall details
- Recalling firm
- Cryolife Inc
- Reason for recall
- CryoLife conducted a retrospective review which revealed the sterilization cycle of instruments used during processing of various tissues could not be confirmed as acceptable.
- Action taken
- Consignees were notified by letter on/about May 6, 2004.
- Root cause
- Other
- Status
- Terminated
- Product code
- MIE
- Quantity affected
- 1 unit
- Distribution
- Nationwide, Austria, Canada, Germany
- Date initiated
- 2004-05-06
- Date posted
- 2004-11-03
- Date terminated
- 2010-06-29
- Location
- Kennesaw, GA
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