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U.S. Department of Health and Human Services

Class 2 Device Recall AngioDynamics VenaCure EVLT NeverTouch Procedure Kit

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  Class 2 Device Recall AngioDynamics VenaCure EVLT NeverTouch Procedure Kit see related information
Date Initiated by Firm June 27, 2019
Create Date August 30, 2019
Recall Status1 Terminated 3 on July 29, 2020
Recall Number Z-2444-2019
Recall Event ID 83334
510(K)Number K112600  
Product Classification Powered laser surgical instrument - Product Code GEX
Product AngioDynamics VenaCure EVLT NeverTouch Procedure Kit, 45CM NEVERTOUCH FRS .018 PROCEDURE KIT PG, Catalog Number 11403012
Code Information Lot 5456490; UPN H787114030120
Recalling Firm/
Manufacturer		 Angiodynamics, Inc.
603 Queensbury Ave
Queensbury NY 12804-7619
For Additional Information Contact David Greer
518-742-1676
Manufacturer Reason
for Recall		 The affected product is properly labelled with an expiration date of March 31, 2022; but the RFID programmed expiration date is April-2014 which results in an error message when connected to the laser source and prevents the product from being used.
FDA Determined
Cause 2		 Under Investigation by firm
Action Customers were contacted via telephone on 6/27/19 directing them to stop using the affected product and segregate until receipt of written Recall Notification. Urgent Voluntary Medical Device Recall notification letters were sent to customers on July 2, 2019.
Quantity in Commerce 109
Distribution The products were distributed to the following US states: DC, IL, IN, MI, NJ, TN, TX, and WI.
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 and Original Applicant = ANGIODYNAMICS, INC.
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