BEUDAMED
    FDA Enforcement Class I Ongoing

    EcoGel 100 - RED Medical Supplies Green Ultrasound Gel, Model No. 250UG-GLU

    Recall: Z-0090-2022 · Reported October 20, 2021

    Enforcement

    Recall Number
    Z-0090-2022
    Event ID
    88726
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Red Medical Supplies
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    October 20, 2021
    Initiation Date
    August 11, 2021
    Classification Date
    October 13, 2021
    Address
    1037 Broadway W Unit 101, N/A, Vancouver, N/A, N/A, Canada

    Description

    EcoGel 100 - RED Medical Supplies Green Ultrasound Gel, Model No. 250UG-GLU

    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 product manufactured by Eco-Med between 2020.09.23 - 2021.08.08

    Distribution

    Firm sold product through Amazon.com. Domestic distribution nationwide.

    Quantity

    639