CryoValve, Pulmonary Valve and Conduit
This recall has been terminated (originally issued July 20, 2004).
- Company
- Cryolife Inc
- Recall Initiated
- February 18, 2004
- Posted
- July 20, 2004
- Terminated
- March 30, 2004
- Recall Number
- Z-0747-04
- Quantity
- 1 unit
- Firm Location
- Kennesaw, GA
- Official Source
- View on FDA website ↗
Reason for Recall
CryoLife received additional information after release of tissue indicating the donor had repeatedly reactive test results for antibody to HCV (EIA) in 1995.
Distribution
DC, TX
Lot / Code Info
Donor #68607, Serial #8044091, Model #PV00
Root Cause
Other
Action Taken
Consignees were notified by telephone on 02/18/2004.
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