BEUDAMED
    FDA Enforcement Class I Terminated

    LiquaSonic Ultrasound Gel 250mL, Model No. 001205

    Recall: Z-2391-2021 · Reported September 15, 2021

    Enforcement

    Recall Number
    Z-2391-2021
    Event ID
    88540
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Athena Medical Products Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 15, 2021
    Initiation Date
    August 20, 2021
    Classification Date
    September 9, 2021
    Termination Date
    February 2, 2023
    Address
    11270 Groome Rd St # B, N/A, Cincinnati, OH, 45242, United States

    Description

    LiquaSonic Ultrasound Gel 250mL, Model No. 001205

    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

    UDI 00856589006120, All lot codes. Product will be discontinued and will not be reintroduced.

    Distribution

    Distributed to one distributor within the US.

    Quantity

    12,240 cases of 12