CryoValve, Aortic Valve & Conduit
- Company
- Cryolife Inc
- Recall Initiated
- May 6, 2004
- Posted
- November 3, 2004
- Terminated
- June 29, 2010
- Recall Number
- Z-0166-05
- Quantity
- 20 units
- Firm Location
- Kennesaw, GA
Reason for Recall
CryoLife conducted a retrospective review which revealed the sterilization cycle of instruments used during processing of various tissues could not be confirmed as acceptable.
Distribution
Nationwide, Austria, Canada, Germany
Lot / Code Info
Donor #25741, Serial #6048048, Model #PV00* Donor #34696, Serial #6356176, Model #PV00* Donor #40017, Serial #6528252, Model #AV00* Donor #41180, Serial #6575609, Model #AV00* Donor #41204, Serial #6575862, Model #AV00* Donor #41737, Serial #6593488, Model #AV00* Donor #45446, Serial #6714974, Model #AV00* Donor #45592, Serial #6735875, Model #AV00* Donor #46183, Serial #6736590, Model #AV00* Donor #46484, Serial #6774373, Model #AV00* Donor #46505, Serial #6770996, Model #AV00* Donor #47518, Serial #6761788, Model #AV00* Donor #50045, Serial #7110160, Model #AV00* Donor #50098, Serial #7106597, Model #AV00* Donor #50953, Serial #7000596, Model #AV00* Donor #50982, Serial #7090443, Model #AV00* Donor #53789, Serial #7013389, Model #AV00* Donor #54935, Serial #7235057, Model #AV00* Donor #59111, Serial #7343716, Model #AV00* Donor #59407, Serial #7322607, Model #AV00
Root Cause
Other
Action Taken
Consignees were notified by letter on/about May 6, 2004.