FDA Enforcement
Class II
Terminated
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.
Recall: Z-1069-2014
·
Reported March 5, 2014
Enforcement
- Recall Number
- Z-1069-2014
- Event ID
- 67193
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Terumo Cardiovascular Systems Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 5, 2014
- Initiation Date
- December 12, 2013
- Classification Date
- February 21, 2014
- Termination Date
- July 28, 2015
- Address
- 125 Blue Ball Rd, Elkton, MD, 21921-5315, United States
Description
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.
Reason
Sterility of medical devices intended for use in surgical procedures may be compromised.
Code Info
Lot numbers: 21K, 31K, 32K, 33K, 34K, 35K
Distribution
USA Nationwide Distribution in the state of LA, NJ, and NY.
Quantity
26 units