CryoValve, Pulmonary Valve
This recall has been terminated (originally issued November 3, 2004).
- Company
- Cryolife Inc
- Recall Initiated
- May 6, 2004
- Posted
- November 3, 2004
- Terminated
- June 29, 2010
- Recall Number
- Z-0171-05
- Quantity
- 1 unit
- Firm Location
- Kennesaw, GA
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide, Austria, Canada, Germany
Lot / Code Info
Donor #59446, Serial #7352907, Model #PV10
Root Cause
Other
Action Taken
Consignees were notified by letter on/about May 6, 2004.
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