Recall Z-2444-2019 ยท GEX Powered Laser Surgical Instrument
Angiodynamics, Inc.
AngioDynamics VenaCure EVLT NeverTouch Procedure Kit, 45CM NEVERTOUCH FRS .018 PROCEDURE KIT PG, Catalog Number 11403012
| Date | Jun 27, 2019 |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112600 | ANGIODYNAMICS, INC. VENACURE NEVERTOUCH DIRECT PROCEDURE KIT AngioDynamics, Inc., Jan 30, 2012 |