Device Recall CLEARGLIDE PRECISION BIPOLAR DEVICE

Lot numbers: 0910300035, 0911100013, 0911700032, 0912400207, 0913100044, 0921500031, 0923700087, 0924300023, 0925100112, 0925100116, 092700175, 0929400008, 0929900092, 0930700014.

General and Plastic Surgery Devices

2

No

Worldwide Distribution -- United States, Australia, Canada and Italy.

Sorin / Clearglide EVH Small, REF KTV15, 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.

Lot Num,bers: 0910500009, 0912400208, 0915300001, 0922900039, 0925100117, 0927200177, 0929900093.

General and Plastic Surgery Devices

2

No

Worldwide Distribution -- United States, Australia, Canada and Italy.

Sorin / Clearglide EVH Low Profile, REF KTV16, 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.

Lot Numbers: 0910300012, 0910500010, 0915300002, 0925100118, 0927200179, 0929900095.

General and Plastic Surgery Devices

2

No

Worldwide Distribution -- United States, Australia, Canada and Italy.

Sorin / Clearglide EVH Low Profile with Scissor, REF KTV18, 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.

Lot Numbers: 0914600039, 0930700018.

General and Plastic Surgery Devices

2

No

Worldwide Distribution -- United States, Australia, Canada and Italy.

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.

Lot Numbers: 0916600195, 0925100114, 0922900040, 0927200176, 0929400009.

General and Plastic Surgery Devices

2

No

Worldwide Distribution -- United States, Australia, Canada and Italy.

Sorin / Clearglide EVH Long View with Scissor, REF KTV23, 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.