Class 2 Device Recall VenaCure EVLT

• Date Initiated by Firm: November 10, 2011
• Date Posted: January 11, 2012
• Recall Status: Terminated on February 01, 2016
• Recall Number: Z-0402-2012
• Recall Event ID: 60467
• 510(K)Number: K102796
• Product Classification: Powered laser surgical instrument - Product Code GEX
• Product: 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 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.
• Code Information: Batch/Lot Numbers: 549604, 549605, 549607, 549806, 549991, 550848, 551098, 551099, 551100, 551101, 551102, 551503, 551970, 551971, 551972, 551973, 551974, 552939, 552960, 553299, 553300, 553301, 553302, 553583, 553605, 553937, 553938, 553939, 554040, 554041, 554267, 554268, 554269, 554270, 554624
• Recalling Firm/ Manufacturer: Angiodynamics Worldwide Headquarters; 14 Plaza Drive; Latham NY 12110-3421
• For Additional Information Contact: Teri Juckett; 518-795-1142
• Manufacturer Reason for Recall: 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.
• FDA Determined 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#) will be assigned to each customer in the recall notification letter, an UPS account will be provided for return freight and a replacement product will be shipped upon receipt and confirmation of the returned product. If you have any additional questions or concerns or need more detailed instruction on how to comply with this notice, please do not hesitate to contact your local sales representative or call the Customer Service Manager, at ANGIODYNAMICS Customer Service at 1-800-772-6446. You may also e-mail your questions to customerservice@angiodynamics.com.
• Quantity in Commerce: 3165 units
• Distribution: Worldwide Distribution - USA (nationwide) and the countries of: Canada, Great Britain, France, India, New Zealand, Netherlands, Saudi Arabia, Turkey, and Singapore
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = GEX