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

Recall date

June 27, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2444-2019

FDA classification

Class II

Brand / firm

Angiodynamics, Inc.

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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