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U.S. Department of Health and Human Services

Class 2 Device Recall VenaCureEVLT

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  Class 2 Device Recall VenaCureEVLT see related information
Date Initiated by Firm December 06, 2011
Date Posted January 13, 2012
Recall Status1 Terminated 3 on February 05, 2016
Recall Number Z-0739-2012
Recall Event ID 60591
Product Classification Powered laser surgical instrument - Product Code GEX
Product VenaCureEVLT Perforator Vein Ablation Kit, CATALOG #: EVLT/PVAK, STERILE -- Manufactured for: AngioDynamics Inc. 603 Queensbury, NY 12804 USA, AngioDynamics UK Limited, Building 2000, Beach Drive, IQ Cambridge, Waterbeach, Cambridge, CB259TE, United Kingdom --- COMMON/USUAL NAME: Laser Surgical Instrument; CLASSIFICATION NAME: Powered Laser Surgical Instrument; DEVICE LISTING # D053485. --- Product Usage: The 810nm Diomed Laser and EVLT Procedure Kit are intended for use in the treatment of superficial vein reflux of the greater saphenous vein associated with varicosities. The Diomed D15 plus and D30 plus and EVLT Kits are indicated for treatment of incompetence and reflux of superficial veins in the lower extremity.
Code Information Batch/Lot Numers: 005813A, 005813B, 005854, 005854A, 005855, 005856, 005903, 005904, 005905, 005918, 005919, 005920, 005921, 005922, 005929, 005930, 005931, 005932, 005933, 005942, 005943, 005944, 005945, 005946, 005947, 005948, 005966, 005967, 005968, 005969, 005970 
Recalling Firm/
Angiodynamics Worldwide Headquarters
14 Plaza Drive
Latham NY 12110-3421
For Additional Information Contact Teri Juckett
Manufacturer Reason
for Recall
The product was labeled with a specific indication for the treatment of perforator veins and this specific indication had not received FDA clearance prior to the product being marketed in the US.
FDA Determined
Cause 2
Error in labeling
Action Angiodynamics sent an Urgent Medical Device Recall Letters and Response Forms dated December 2, 2011 to all affected consignees via Certified Mail on December 6, 2011. The recall was extended to the medical user level. The letter identified the product, problem, and actions to be taken. Customers were instructed not to use the product and to return recalled product to AngioDynamics, Inc. in Queensbury, NY. The letter states if the affected product/lot have been distributed, please inform your customers of this recall action immediately and have them return the recalled units. For questions or concerns call the Customer Service Manager at ANGIODYNAMICS Customer Service at 1-800-722-6446.
Quantity in Commerce 7640 units domestically
Distribution (USA) Nationwide Distribution
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.