CryoValve, Pulmonary Valve & Conduit
This recall has been terminated (originally issued November 30, 2005).
- Company
- Cryolife Inc
- Recall Initiated
- November 19, 2003
- Posted
- November 30, 2005
- Terminated
- July 2, 2009
- Recall Number
- Z-0217-06
- Quantity
- 8 units
- Firm Location
- Kennesaw, GA
- Official Source
- View on FDA website ↗
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 #68206, Serial #7960244, Model #PV00, Donor #68241, Serial #7971710, Model #PV00, Donor #68422, Serial #8047344, Model #PV00, Donor #69368, Serial #8022398, Model #PV00, Donor #69826, Serial #8071361, Model #PV00, Donor #69934, Serial #8059703, Model #PV00, Donor #67086, Serial #7993957, Model #PV00, Donor #30309, Serial #6218156, Model #PV00
Root Cause
Other
Action Taken
Consignees were notified by letter starting 11/17/2003.