BEUDAMED
    FDA Enforcement Class I Ongoing

    Brand Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Model/Catalog Number: 0830 Software Version: N/A Product Description: Reusable Patient Return Electrode, Mega Soft, Single Cord, Adult, For Patients Weighing over 25lbs (11.4Kg), 117cm Long x 51cm Wide x 1.25cm Thick Component: No

    Recall: Z-2249-2024 · Reported July 10, 2024

    Enforcement

    Recall Number
    Z-2249-2024
    Event ID
    94837
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Megadyne Medical Products, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 10, 2024
    Initiation Date
    June 17, 2024
    Classification Date
    July 3, 2024
    Address
    4545 Creek Rd, N/A, Blue Ash, OH, 45242-2803, United States

    Description

    Brand Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Model/Catalog Number: 0830 Software Version: N/A Product Description: Reusable Patient Return Electrode, Mega Soft, Single Cord, Adult, For Patients Weighing over 25lbs (11.4Kg), 117cm Long x 51cm Wide x 1.25cm Thick Component: No

    Reason

    To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential risk of patient burns identified with use of Mega Soft pads.

    Code Info

    Product Code: 0830; UDI-DI: 10614559101797; Lot Number: All distributed lot numbers. Product code has been discontinued from future production.

    Distribution

    Domestic: Nationwide distribution International: AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, CANADA, CHINA, GERMANY, GREECE, INDIA, ITALY, NETHERLANDS, NORWAY, JAPAN, SAUDI ARABIA, SINGAPORE, SOUTH KOREA, SPAIN, THAILAND, TURKEY, UNITED KINGDOM, UNITED STATES,

    Quantity

    2584 units