FDA Medical Device Recalls (openFDA)
Angiodynamics, Inc.: AngioDynamics VenaCure EVLT NeverTouch Procedure Kit, 45CM NEVERTOUCH FRS .018 PROCEDURE KIT PG, Catalog Number 11403012
- Recall number
- Z-2444-2019
- Recalling firm
- Angiodynamics, Inc.
- Product
- AngioDynamics VenaCure EVLT NeverTouch Procedure Kit, 45CM NEVERTOUCH FRS .018 PROCEDURE KIT PG, Catalog Number 11403012
- Status
- Terminated
- Initiated
- 2019-06-27
- Posted
- not on file
- Terminated
- 2020-07-29
- Reason
- 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.
- Root cause
- 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
- 109
- Distribution
- The products were distributed to the following US states: DC, IL, IN, MI, NJ, TN, TX, and WI.
- Lot, serial or model codes
- Lot 5456490; UPN H787114030120
- 510(k) numbers
- ["K112600"]
- PMA numbers
- not on file
- Product code
- GEX
- Firm FEI
- 1319211
- Firm city
- Queensbury
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28