BEUDAMED
    FDA Enforcement Class I Ongoing

    ECO 50TS Gel Tens Ultrasound 1in X 5L cube 1 Dispenser Btl

    Recall: Z-0068-2022 · Reported October 20, 2021

    Enforcement

    Recall Number
    Z-0068-2022
    Event ID
    88640
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    National Distribution & Contracting Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 20, 2021
    Initiation Date
    August 24, 2021
    Classification Date
    October 13, 2021
    Address
    407 New Sanford Rd, N/A, La Vergne, TN, 37086-4184, United States

    Description

    ECO 50TS Gel Tens Ultrasound 1in X 5L cube 1 Dispenser Btl

    Reason

    Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination.

    Code Info

    All lots for the following distributed product code: Product Code: ECO 50TS - ECO 50TS Gel Tens Ultrasound 1in X 5L cube 1 Dispenser

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of RI, AL, AR, AZ, CA, CO, CT, FL, GA, GU, HI, IA, IL, IN, KS, KY, MA, MD, LA, ME, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OK, PA, SC, SD, TN, TX, VA, WA and the countries of Canada and Nova Scotia.

    Quantity

    3 units