FDA-Device2014-03-05Class II

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.

Terumo Cardiovascular Systems Corporation
Hazard

Sterility of medical devices intended for use in surgical procedures may be compromised.

Sold states
USA Nationwide Distribution in the state of LA, NJ, and NY.
Affected count
26 units
Manufactured in
125 Blue Ball Rd, Elkton, MD, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1069-2014

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