BEUDAMED
    FDA Enforcement Class I Ongoing

    MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. used during electrosurgery

    Recall: Z-1997-2023 · Reported July 5, 2023

    Enforcement

    Recall Number
    Z-1997-2023
    Event ID
    92409
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Megadyne Medical Products, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 5, 2023
    Initiation Date
    June 1, 2023
    Classification Date
    June 29, 2023
    Address
    4545 Creek Rd, N/A, Blue Ash, OH, 45242-2803, United States

    Description

    MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. used during electrosurgery

    Reason

    Firm has received reports of patient burns in surgical procedures where device was used.

    Code Info

    Model No. 0840; UDI-DI: 10614559103395; All Units.

    Distribution

    Distributed US Nationwide.

    Quantity

    21,100 units