Device product
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.
Z-1069-2014
Product summary
- Event
- Event 67193
- Status
- Terminated
- Classification
- Class II
- Quantity
- 26 units
- Official record key
device-enforcement:Z-1069-2014
Official wording
Reason: Sterility of medical devices intended for use in surgical procedures may be compromised.
Code information: Lot numbers: 21K, 31K, 32K, 33K, 34K, 35K
Distribution pattern: USA Nationwide Distribution in the state of LA, NJ, and NY.
Derived failure modes
-
Unknown
Sterility of medical devices intended for use in surgical procedures may be compromised.