CryoValve, Pulmonary Valve & Conduit
- Company
- Cryolife Inc
- Recall Initiated
- May 6, 2004
- Posted
- February 4, 2006
- Terminated
- June 28, 2010
- Recall Number
- Z-0477-06
- Quantity
- 6 units
- Firm Location
- Kennesaw, GA
Reason for Recall
During a retrospective review, CryoLife identified positive microbiological culture results for donor tissues associated with various allografts.
Distribution
FL, NC , NE, NV, NY, TN, TX, UT, WA, and Canada
Lot / Code Info
Donor #40658, Serial #6547591, Model #PV00* Donor #40914, Serial #6565514, Model #PV00* Donor #52097, Serial #7082478, Model #PV00* Donor #52100, Serial #7085341, Model #PV00* Donor #52647, Serial #7075544, Model #PV00* Donor #54259, Serial #7284361, Model #PV00
Root Cause
Other
Action Taken
Consignees were notified by letter dated May 6, May 11, or May 12, 2004.
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