Recall Z-1069-2014 ยท GCJ Laparoscope, General & Plastic Surgery
Terumo Cardiovascular Systems Corporation
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.
| Date | Feb 21, 2014 (initiated Dec 12, 2013) |
| Status | Terminated |
| Reason | Sterility of medical devices intended for use in surgical procedures may be compromised. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 26 units |
| Distribution | USA Nationwide Distribution in the state of LA, NJ, and NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092789 | VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM Terumo Cardiovascular Systems Corp., May 12, 2010 |