CryoValve Allograft, Heart valve
This recall has been terminated (originally issued May 22, 2003).
- Company
- Cryolife Inc
- Recall Initiated
- April 30, 2003
- Posted
- May 22, 2003
- Terminated
- April 29, 2004
- Recall Number
- Z-0866-03
- Quantity
- 8 units
- Firm Location
- Kennesaw, GA
- Official Source
- View on FDA website ↗
Reason for Recall
Microorganisms were detected in associated allografts.
Distribution
The components were distributed to hospitals and physicians located in CA, IL IN, , NM, OH and OK.
Lot / Code Info
Donor #61838, Serial #7691913, Model #SGPV00; Donor #65235, Serial #7915089, Model #SGAV00, Donor #64922, Serial #7883079, Model #SGAV00; Donor #64779, Serial #7883080, Model #SGPV00; Donor #64779 77888910, Model #SGPV00; Donor #64779, Serial #7888909, Model #SGAV00; and Donor #63941, Serial #7894710, Model #SGPV00.
Root Cause
Other
Action Taken
Implanting physicians were notified via letter on April 30, 2003. They were advised to quarantine and return the allograft if not implanted. A self addressed, stamped postcard was included to affirm receipt of the notice and to provide information of final disposition of the allograft.