CryoValve, Aortic Valve and Conduit
This recall has been terminated (originally issued March 10, 2005).
- Company
- Cryolife Inc
- Recall Initiated
- December 17, 2004
- Posted
- March 10, 2005
- Terminated
- January 27, 2006
- Recall Number
- Z-0581-05
- Quantity
- 1 tissue
- Firm Location
- Kennesaw, GA
- Official Source
- View on FDA website ↗
Reason for Recall
Records noted that the infant donor's mother had tested positive for Hepatitis B.
Distribution
CA, FL
Lot / Code Info
Donor #62654, Serial #7816174, Model #AV00
Root Cause
Other
Action Taken
Physicians were notified by letter on 12/17/2004.
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