CryoValve, Pulmonary Valve and Conduit
This recall has been terminated (originally issued April 6, 2005).
- Company
- Cryolife Inc
- Recall Initiated
- January 12, 2005
- Posted
- April 6, 2005
- Terminated
- April 12, 2005
- Recall Number
- Z-0669-05
- Quantity
- 1 tissue
- Firm Location
- Kennesaw, GA
- Official Source
- View on FDA website ↗
Reason for Recall
During a retrospective review CryoLife's Medical Director identified pre-processing and incoming bioburden cultures of the heart tissue, which detected Staphylococcus aureas.
Distribution
KS
Lot / Code Info
Donor Number: 70022, Serial Number: 8056613, Model Number: PV00
Root Cause
Other
Action Taken
Consignee was notified by letter on 01/12/2005.
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