BEUDAMED
    FDA Enforcement Class I Ongoing

    Ultra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossage Lotion 1-gallon bottle, REF: 4210, located in the following DJO, LLC / DJO FRANCE kits:

    Recall: Z-0010-2022 · Reported October 13, 2021

    Enforcement

    Recall Number
    Z-0010-2022
    Event ID
    88623
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    DJO, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 13, 2021
    Initiation Date
    September 7, 2021
    Classification Date
    October 5, 2021
    Address
    5919 Sea Otter Pl Ste 200, Carlsbad, CA, 92010-6750, United States

    Description

    Ultra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossage Lotion 1-gallon bottle, REF: 4210, located in the following DJO, LLC / DJO FRANCE kits:

    Reason

    Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-letter-health.

    Code Info

    All Lots manufactured by Eco-Med Pharmaceutical, Inc

    Distribution

    Worldwide distribution - U.S. Nationwide distribution including in the states of ND, NJ, CO, HI, CA, MA, FL, GA, IN, WA, NY, TX, IA, TN, NV, LA, CT, VA, NC, WI, MS, OR, MI, AL, MN, VT, IL, OH, AR, NM, DE, PA, SC, AZ, MD, RI, KY, UT, MO, OK, MT, ID, NE, WY, ME, WV, SD, KS, PR, NH, DC, AK, VI and the countries of France, China, Mexico, Ontario, Australia.

    Quantity

    8,702