BEUDAMED
    FDA Enforcement Class I Ongoing

    Product Code 0847, MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Plus

    Recall: Z-0599-2024 · Reported January 3, 2024

    Enforcement

    Recall Number
    Z-0599-2024
    Event ID
    93597
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Megadyne Medical Products, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 3, 2024
    Initiation Date
    December 8, 2023
    Classification Date
    December 26, 2023
    Address
    4545 Creek Rd, Blue Ash, OH, 45242-2803, United States

    Description

    Product Code 0847, MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Plus

    Reason

    Affected product codes are now limited to use in patients age 12 years or older. Megadyne has received reports of patient burn injuries up to and including third-degree burns requiring intervention which may lead to prolonged hospital stay, scarring, and additional surgeries in both pediatric and adult patients.

    Code Info

    UDI-DI 10614559104842 All units in expiry

    Distribution

    Worldwide distribution. US Nationwide including Puerto Rico; Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Czechia, Denmark, Egypt, Eswatini, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kosovo, Kuwait, Lebanon, Malaysia, Martinique, Morocco, Netherlands, New Caledonia, Norway, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian , Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and Vietnam

    Quantity

    2,312