CryoValve, Pulmonary Valve
- Company
- Cryolife Inc
- Recall Initiated
- November 19, 2003
- Posted
- November 30, 2005
- Terminated
- July 2, 2009
- Recall Number
- Z-0216-06
- Quantity
- 1 unit
- Firm Location
- Kennesaw, GA
Reason for Recall
Previously released tissues no longer meet CryoLife's enhanced suitability release criteria because donors possessed a positive post processing microbiological culture of 'potentially pathogenic' organisms.
Distribution
AR, AZ, CA, CT, DC, FL, IL, LA, MN, NC, NH, NV, NY, TN, TX, UT, and Germany.
Lot / Code Info
Donor #29558, Serial #6190065, Model #PV10
Root Cause
Other
Action Taken
Consignees were notified by letter starting 11/17/2003.
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