Pulmonary Valve & Conduit SG Used in heart surgery
This recall has been terminated (originally issued February 11, 2011).
- Company
- Cryolife Inc
- Recall Initiated
- January 7, 2011
- Posted
- February 11, 2011
- Terminated
- November 1, 2011
- Recall Number
- Z-1219-2011
- Quantity
- One
- Firm Location
- Kennesaw, GA
- Official Source
- View on FDA website ↗
Reason for Recall
A pre-processing culture performed on a companion allograft (Aortic Valve & Conduct SG) tested positive for Staphylococcus aureus.
Distribution
Nationwide distribution: USA state of: MI
Lot / Code Info
Serial Number 9748180
Root Cause
Other
Action Taken
The firm, Cryolife, sent an "Urgent-Human Tissue Recall" letter dated January 7, 2011 to the consignee/customer. The letter describe the product, problem and action to be taken by the customer. The customer was instructed to determine if any additional patient surveillance or intervention was necessary, and to complete and return the enclosed postcard affirming that the notification was received. If you have any questions, please contact Cryolife's Medical Director at 1-678-290-4403.