BEUDAMED
    FDA Recall Open, Classified

    EcoGel 200 - RED Medical Supplies Clear Ultrasound Gel, Model No. 250UG-CMU

    Recall: Z-0089-2022 · Initiated August 11, 2021

    Recall

    Recall Number
    Z-0089-2022
    Event Number
    88726
    Firm
    Red Medical Supplies
    FEI Number
    3012307634
    Product Code
    ITX
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    August 11, 2021
    Address
    1037 Broadway W, Unit 101, Vancouver Canada

    Description

    EcoGel 200 - RED Medical Supplies Clear Ultrasound Gel, Model No. 250UG-CMU

    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.

    Action

    According to the firm, Amazon.com has issued recall notification to all customers via email. Customers were instructed to return the product as soon as possible. An automatic refund has been issued by Amazon.com as soon as the product was recalled. Amazon.com is in charge of the disposal.

    Distribution

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

    Quantity

    2000