Pulmonary Valve & Conduit
- Company
- Cryolife Inc
- Recall Initiated
- May 17, 2005
- Posted
- June 1, 2005
- Terminated
- June 1, 2005
- Recall Number
- Z-0860-05
- Quantity
- 1 unit
- Firm Location
- Kennesaw, GA
Reason for Recall
Subsequent to tissue release, CryoLife received new information related to the donor time of death, which caused the donor to no longer meet CryoLife's acceptance criteria for warm ischemic time.
Distribution
IL, MT
Lot / Code Info
Donor #77647, Serial #8471383, Model #PV00
Root Cause
Other
Action Taken
Consignees were notified by telephone on May 17, 2005. Both tissues were returned and destroyed.
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