FDA recall Z-2444-2019

Product

AngioDynamics VenaCure EVLT NeverTouch Procedure Kit, 45CM NEVERTOUCH FRS .018 PROCEDURE KIT PG, Catalog Number 11403012

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.

Distribution

The products were distributed to the following US states: DC, IL, IN, MI, NJ, TN, TX, and WI.

Key facts

Status

Terminated

Initiation date

2019-06-27

Report date

2019-09-11

Termination date

2020-07-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Queensbury, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2444-2019