Pulmonary Valve & Conduit SG Used in heart surgery
This recall has been terminated (originally issued March 4, 2011).
- Company
- Cryolife Inc
- Recall Initiated
- February 17, 2011
- Posted
- March 4, 2011
- Terminated
- April 24, 2012
- Recall Number
- Z-1560-2011
- Quantity
- One
- Firm Location
- Kennesaw, GA
- Official Source
- View on FDA website ↗
Reason for Recall
Staphylococcus aureus (not methicillin resistant) identified in companion tissue.
Distribution
Nationwide Distribution including AZ & NV
Lot / Code Info
Serial No. 9560908 - Model SGPV00
Root Cause
Other
Action Taken
CryoLife Inc. issued a letter to the physician on February 17, 2011, advising him of the results of the testing performed on a companion cardiac allograft. The letter did not recommend explant of the allograft or special antimicrobial treatment of the patient unless medically necessary. The physician was asked to complete and return the enclosed, stamped, self-addressed postcard affirming the receipt of the notification. For any questions the physician was advised to call 770-419-3355.