BEUDAMED
    FDA Enforcement Class II Terminated

    R-F Injector Cannula. 18gx10cm-STERILE. REF/UDI: 257-1810/(01)00828788021496; REF/UDI: 257-1810D(01)10818788021493 - Product Usage: The Epimed RF Introduction Cannula is intended for use in radiofrequency (RF) heat lesion procedures for the relief of pain.

    Recall: Z-1849-2020 · Reported May 13, 2020

    Enforcement

    Recall Number
    Z-1849-2020
    Event ID
    85339
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Epimed International
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 13, 2020
    Initiation Date
    February 21, 2020
    Classification Date
    May 4, 2020
    Termination Date
    January 28, 2021
    Address
    13958 Diplomat Dr, N/A, Farmers Branch, TX, 75234-8805, United States

    Description

    R-F Injector Cannula. 18gx10cm-STERILE. REF/UDI: 257-1810/(01)00828788021496; REF/UDI: 257-1810D(01)10818788021493 - Product Usage: The Epimed RF Introduction Cannula is intended for use in radiofrequency (RF) heat lesion procedures for the relief of pain.

    Reason

    Incorrect expiration date on introduction cannula packaging.

    Code Info

    Catalog #257-1810 Sterile Lot #/Expiration Date/ 1. 14108679/exp. 3-29-23/ 2. 14109199/exp. 1-21-24/ 3. 14108568/exp. 2-4-23/ Catalog #257-1810D Sterile Lot #/Expiration Date/ 1. 14109199/ exp. 1-21-24/ 2. 14109690/exp. 9-26-24/

    Distribution

    Worldwide distribution - US Nationwide distribution including the states of AL, CA, FL, GA, IL, MD,MI, MS, NJ, NY, OK, TN, TX, WA and WY and the countries of Australia, Chile, United Kingdom.

    Quantity

    1374