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U.S. Department of Health and Human Services

Class 2 Device Recall VenaCure EVLT

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 Class 2 Recall
VenaCure EVLT
see related information
Date Posted January 11, 2012
Recall Status1 Open
Recall Number Z-0402-2012
Recall Event ID 60467
Premarket Notification
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, New York 12110-3421
Consumer Instructions Contact the recalling firm for information
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 2
PRODUCTION CONTROLS: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GEX and Original Applicant = ANGIODYNAMICS, INC.
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