BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-2444-2019 · Initiated June 27, 2019

    Recall

    Recall Number
    Z-2444-2019
    Event Number
    83334
    Firm
    Angiodynamics, Inc.
    FEI Number
    1319211
    Product Code
    GEX
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    June 27, 2019
    Terminated
    July 29, 2020
    Address
    603 Queensbury Ave, Queensbury, NY, 12804-7619

    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.

    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.

    Distribution

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

    Quantity

    109