CryoValve, Pulmonary Valve and Conduit
This recall has been terminated (originally issued October 1, 2005).
- Company
- Cryolife Inc
- Recall Initiated
- January 26, 2004
- Posted
- October 1, 2005
- Terminated
- October 6, 2005
- Recall Number
- Z-1593-05
- Quantity
- 1 tissue
- Firm Location
- Kennesaw, GA
- Official Source
- View on FDA website ↗
Reason for Recall
Mislabeling; An allograft labeled as an aortic valve & conduit, actually contained a pulmonary valve and conduit.
Distribution
CA
Lot / Code Info
Donor #68538, Serial #8045214, Model #PV00
Root Cause
Other
Action Taken
Consignee was notified by letter on 01/26/2004. The tissue was returned to CryoLife and destroyed.
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