Recalls / —

—#174798

Product

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

FDA product code

GEX — Powered Laser Surgical Instrument

Device class

Class 2

Medical specialty

General, Plastic Surgery

510(k) numbers

K112600

Affected lot / code info

Lot 5456490; UPN H787114030120

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm

Angiodynamics, Inc.

Address

603 Queensbury Ave, Queensbury, New York 12804-7619

Distribution

Distribution pattern

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

Timeline

Recall initiated

2019-06-27

Terminated

2020-07-29

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #174798. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.