Sorin / Clearglide EVH Long View, REF KTV22, Sterile R, Manufactured for: Sorin Group USA, Inc., 14401 W.65th Way, Arvada, CO 80004. The device is indicated for endoscopic and open tissue dissection, bipolar coagulation, and transaction of blood vessels. Device is a single patient use bipolar instrument that uses a bipolar electrosurgical generator and is used predominately for endoscopic harvesting of the saphenous vein from the leg for coronary bypass surgery.
Recall
- Recall Number
- Z-0628-2010
- Event Number
- 54000
- Firm
- Sorin Group USA, Inc.
- FEI Number
- 1718850
- Product Code
- GEI
- Status
- Terminated
- Root Cause
- Component change control
- Initiated
- November 25, 2009
- Posted
- January 14, 2010
- Terminated
- October 4, 2010
- Address
- 14401 W 65th Way, Arvada, CO, 80004
Description
Sorin / Clearglide EVH Long View, REF KTV22, Sterile R, Manufactured for: Sorin Group USA, Inc., 14401 W.65th Way, Arvada, CO 80004. The device is indicated for endoscopic and open tissue dissection, bipolar coagulation, and transaction of blood vessels. Device is a single patient use bipolar instrument that uses a bipolar electrosurgical generator and is used predominately for endoscopic harvesting of the saphenous vein from the leg for coronary bypass surgery.
Vessel clamping device may break during use.
Consignees were notified by "Urgent Field Safety Notice" dated November 24, 2009 with instructions to examine the device before, during and after use. Customers were instructed to not use the device, if it is damaged. Customers were also instructed to contact the Sorin Group Customer Service at 1-800-650-2623 to arrange shipment of replacement product and requested to complete and return the response form. Direct questions to the Sorin Group Customer Service at 1-800-650-2623.
Worldwide Distribution -- United States, Australia, Canada and Italy.
3 units