BEUDAMED
    FDA Enforcement Class I Ongoing

    Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue.

    Recall: Z-0029-2022 · Reported October 13, 2021

    Enforcement

    Recall Number
    Z-0029-2022
    Event ID
    88624
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Aesthetics Systems Usa Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 13, 2021
    Initiation Date
    August 23, 2021
    Classification Date
    October 6, 2021
    Address
    1149 Pomona Rd Ste J, Corona, CA, 92882-7600, United States

    Description

    Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue.

    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 with valid expiration dates

    Distribution

    U.S. Nationwide distribution in the states of WA, TX, AK, AZ, CA.

    Quantity

    23