Recall Z-0402-2012 ยท GEX Powered Laser Surgical Instrument
Angiodynamics Worldwide Headquarters
VenaCure EVLT NeverTouch - FRS PROCEDURE KIT Featuring Gold-Tipped Fiber, 45 cm, NeverTouch 45cm Kit w/Gripper and RFID T, Catalog No./REF 11403001, 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 th
| Date | Jan 11, 2012 (initiated Nov 10, 2011) |
| Status | Terminated |
| Reason | During an in-process inspection the hemostasis sidearm assemblies were identified to have the potential for flash to exist on the housing at the base of the threads. This flash has the potential to break off and relocate within the fluid path. |
| Root cause | Process control |
| Action | AngioDynamics sent an URGENT: Medical Device Recall letters and response form (dated November 10, 2011) to all affected customers. The letter identified the affected products, the problem, and the actions to be taken by customer/user. The customers were instructed to do the following: 1) Identify, segregate and return the recalled products to ANGIODYNAMICS and 2) Complete the enclosed Recall Reply Form even if they do not have any products remaining in their possession, noting zero quantity to be returned and fax to 518-798-1360. The letter states that a returned authorization number (RA#) |
| Quantity | 3165 units |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of: Canada, Great Britain, France, India, New Zealand, Netherlands, Saudi Arabia, Turkey, and Singapore |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102796 | ANGIODYNAMICS, INC. VENACURE PROCEDURE KIT AngioDynamics, Inc., Dec 15, 2010 |