Device Recall VenaCure EVLT

Batch/Lot Numbers: 549019, 549040, 549041, 549599, 549600, 549601, 549602, 549603, 549803, 549804, 549805, 551095, 551096, 551097

General and Plastic Surgery Devices

2

No

Worldwide Distribution - USA (nationwide) and the countries of: Canada, Great Britain, France, India, New Zealand, Netherlands, Saudi Arabia, Turkey, and Singapore

VenaCure EVLT¿ NeverTouch PROCEDURE KIT Featuring Gold-Tipped Fiber, 65 cm, NeverTouch Kit 65CM Internal Sheath, Catalog No./REF 11402002, STERILE -- AngioDynamics, Inc. 603 Queensbury, NY USA 12804. || Product Usage: The AngioDynamics, Inc. VenaCure Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity.

Batch/Lot Numbers: 549594, 549802

General and Plastic Surgery Devices

2

No

Worldwide Distribution - USA (nationwide) and the countries of: Canada, Great Britain, France, India, New Zealand, Netherlands, Saudi Arabia, Turkey, and Singapore

VenaCure EVLT¿ NeverTouch PROCEDURE KIT Featuring Gold-Tipped Fiber, 45 cm, NeverTouch Kit 45CM Internal Sheath, Catalog No./REF 11402001, STERILE -- AngioDynamics, Inc. 603 Queensbury, NY USA 12804. || Product Usage: The AngioDynamics, Inc. VenaCure Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity.

Batch/Lot Numbers: 549045, 549046, 549047, 549609, 549610, 549611, 549612, 549613, 549614, 549807, 549808, 549809, 549810, 551103, 551104, 551105, 551504, 551505, 551506, 551975, 551976, 551977, 551978, 551979, 552961, 552962, 552963, 553303, 553304, 553305, 553306, 553584, 553585, 553586, 554271, 554272, 554273, 554274, 554275, 554276, 554630, 554631, 554632, 554636

General and Plastic Surgery Devices

2

No

Worldwide Distribution - USA (nationwide) and the countries of: Canada, Great Britain, France, India, New Zealand, Netherlands, Saudi Arabia, Turkey, and Singapore

VenaCure EVLT¿ NeverTouch - FRS PROCEDURE KIT Featuring Gold-Tipped Fiber, 65 cm, NeverTouch 65cm Kit w/Gripper and RFID T, Catalog No./REF 11403002, STERILE -- AngioDynamics, Inc. 603 Queensbury, NY USA 12804. || Product Usage: The AngioDynamics, Inc. VenaCure Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity.

Batch/Lot Numbers: 549811, 550576, 552000, 552964, 552965, 554277, 554278

General and Plastic Surgery Devices

2

No

Worldwide Distribution - USA (nationwide) and the countries of: Canada, Great Britain, France, India, New Zealand, Netherlands, Saudi Arabia, Turkey, and Singapore

VenaCure EVLT¿ NeverTouch - FRS .018" System PROCEDURE KIT Featuring Gold-Tipped Fiber, 25 cm, VC EVLT NeverTouch-FRS 0.18 25 cm Kit, Catalog No./REF 11403003, STERILE -- AngioDynamics, Inc. 603 Queensbury, NY USA 12804. || Product Usage: The AngioDynamics, Inc. VenaCure Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity.

Batch/Lot Numbers: 549745, 549746

General and Plastic Surgery Devices

2

No

Worldwide Distribution - USA (nationwide) and the countries of: Canada, Great Britain, France, India, New Zealand, Netherlands, Saudi Arabia, Turkey, and Singapore

VenaCure EVLT¿ NeverTouch - FRS PROCEDURE KIT Featuring Gold-Tipped Fiber, 90 cm, VC EVLT NeverTouch-FRS 90cm Kit, Catalog No./REF 11403004, STERILE -- AngioDynamics, Inc. 603 Queensbury, NY USA 12804. || Product Usage: The AngioDynamics, Inc. VenaCure Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity.