Product Wiki · Recalls · U.S. FDA — Device Enforcement

VirtuoSaph¿ Plus Endoscopic Vessel Harvesting System, Part number… — recall Z-1069-2014

U.S. FDA — Device Enforcement · United States · 2013-12-12 · Class II

As described by U.S. FDA — Device Enforcement: 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 patien

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1069-2014
Date of alert
2013-12-12
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Terumo Cardiovascular Systems Corporation
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
USA Nationwide Distribution in the state of LA, NJ, and NY.
Reported risk: Sterility of medical devices intended for use in surgical procedures may be compromised.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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