VirtuoSaph Plus Endoscopic Vessel Harvesting System, Part number: VSP550, Sterile***Rx Only*** Product Usage: The VirtuoSaph Plus Endoscopic Vessel Harvesting System is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass.
This recall has been terminated (originally issued February 21, 2014).
- Recall Initiated
- December 12, 2013
- Posted
- February 21, 2014
- Terminated
- July 28, 2015
- Recall Number
- Z-1069-2014
- Quantity
- 26 units
- Firm Location
- Elkton, MD
- Official Source
- View on FDA website ↗
Reason for Recall
Sterility of medical devices intended for use in surgical procedures may be compromised.
Distribution
USA Nationwide Distribution in the state of LA, NJ, and NY.
Lot / Code Info
Lot numbers: 21K, 31K, 32K, 33K, 34K, 35K
Root Cause
Process control
Action Taken
Terumo CVS notified afected end users by phone on December 12, 2013 and advised that they had become aware that the sterile packaging barrier was breached in specific lots of VirtuoSaph Plus Endoscopic Vessel Harvesting Systems. Customers were requested to return all unused affected product and verify that all users at their institution have been made aware of the risks associated with using the affected devices. For questions call 734-663-4145.