CryoValve, Pulmonary Valve & Conduit
This recall has been terminated (originally issued February 4, 2006).
- Company
- Cryolife Inc
- Recall Initiated
- January 27, 2006
- Posted
- February 4, 2006
- Terminated
- April 4, 2006
- Recall Number
- Z-0480-06
- Quantity
- 1 unit
- Firm Location
- Kennesaw, GA
- Official Source
- View on FDA website ↗
Reason for Recall
Additional serological testing performed after distribution indicates the donor has a past Hepatitis B infection.
Distribution
NY
Lot / Code Info
Donor number 78142, Serial number 8306247, Model number PV00
Root Cause
Other
Action Taken
Physicians were notified by letter on 1/27/2006.
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