BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-2444-2019 · Reported September 11, 2019

    Enforcement

    Recall Number
    Z-2444-2019
    Event ID
    83334
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Angiodynamics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    September 11, 2019
    Initiation Date
    June 27, 2019
    Classification Date
    August 30, 2019
    Termination Date
    July 29, 2020
    Address
    603 Queensbury Ave, N/A, Queensbury, NY, 12804-7619, United States

    Description

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

    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.

    Code Info

    Lot 5456490; UPN H787114030120

    Distribution

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

    Quantity

    109