BEUDAMED
    FDA Enforcement Class I Ongoing

    Omnisound Gel, 250 ml bottle and 5 L container; and EcoGel 200, 250 ml bottle; Manufactured by Eco-Med. For use in ultrasound procedures.

    Recall: Z-2518-2021 · Reported October 6, 2021

    Enforcement

    Recall Number
    Z-2518-2021
    Event ID
    88602
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Accelerated Care Plus Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 6, 2021
    Initiation Date
    August 25, 2021
    Classification Date
    September 24, 2021
    Address
    4999 Aircenter Cir Ste 103, N/A, Reno, NV, 89502-7923, United States

    Description

    Omnisound Gel, 250 ml bottle and 5 L container; and EcoGel 200, 250 ml bottle; Manufactured by Eco-Med. For use in ultrasound procedures.

    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

    Distributed from January 1, 2018 thru August 4, 2021

    Distribution

    US nationwide distribution.

    Quantity

    9436