BEUDAMED
    FDA Recall Terminated

    R-F Injector Cannula. 20gx10cm-STERILE. REF/UDI: 257-2010/(01)10818788022124; REF/UDI: 257-2010D(01)00818788022127 - Product Usage:The Epimed RF Introduction Cannula is intended for use in radiofrequency (RF) heat lesion procedures for the relief of pain.

    Recall: Z-1850-2020 · Initiated February 21, 2020

    Recall

    Recall Number
    Z-1850-2020
    Event Number
    85339
    Firm
    Epimed International
    FEI Number
    1643059
    Product Code
    GXI
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    February 21, 2020
    Posted
    April 16, 2020
    Terminated
    January 28, 2021
    Address
    13958 Diplomat Dr, Farmers Branch, TX, 75234-8805

    Description

    R-F Injector Cannula. 20gx10cm-STERILE. REF/UDI: 257-2010/(01)10818788022124; REF/UDI: 257-2010D(01)00818788022127 - 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.

    Action

    On 02/21/2020, URGENT: MEDICAL DEVICE RECALL letters were sent to customers by way of Standard U.S. Mail services.

    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

    701