FDAFDA · Food and drugs·Recall number Z-1069-2014
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.
Published March 5, 2014 · Recall initiated: December 12, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Sterility of medical devices intended for use in surgical procedures may be compromised.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Distributor
- USA Nationwide Distribution in the state of LA, NJ, and NY.
- Lot
- Lot numbers: 21K, 31K, 32K, 33K, 34K, 35K
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States