CryoValve, Pulmonary Valve & Conduit SG
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-0218-06
- Quantity
- 7 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 #65569, Serial #7949899, Model #SGPV00, Donor #66126, Serial #8111048, Model #SGPV00, Donor #67001, Serial #7996682, Model #SGPV00, Donor #67404, Serial #7972091, Model #SGPV00, Donor #61482, Serial #7692521, Model #SGPV00, Donor #66320, Serial #8099887, Model #SGPV00, Donor #66035, Serial #8103460, Model #SGPV00
Root Cause
Other
Action Taken
Consignees were notified by letter starting 11/17/2003.