CryoValve, Pulmonary Valve and Conduit
This recall has been terminated (originally issued April 6, 2005).
- Company
- Cryolife Inc
- Recall Initiated
- December 17, 2004
- Posted
- April 6, 2005
- Terminated
- June 1, 2005
- Recall Number
- Z-0684-05
- Quantity
- 1 tissue
- Firm Location
- Kennesaw, GA
- Official Source
- View on FDA website ↗
Reason for Recall
During a retrospective review, CryoLife noted that the donor tissue exceeded the acceptable warm ischemic time when utilizing the 'Last Seen Alive' time in their calculation.
Distribution
CA, NJ, TX
Lot / Code Info
Donor #65989, Serial #8095375, Model #PV00
Root Cause
Other
Action Taken
Consignees were notified by letters dated 12/17/2004, 01/03/2005 and 01/19/2005.
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