BEUDAMED
    FDA Enforcement Class II Terminated

    Disposable Subdermal Needle Electrode, Pt/lr, 12 x 0.40mm, product number TE/S46/638, 25 needles per package, sterile.

    Recall: Z-1737-2022 · Reported September 21, 2022

    Enforcement

    Recall Number
    Z-1737-2022
    Event ID
    90733
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Technomed Europe
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 21, 2022
    Initiation Date
    August 9, 2022
    Classification Date
    September 12, 2022
    Termination Date
    April 11, 2024
    Address
    Amerikalaan 71, Maastricht-Airport, N/A, Netherlands

    Description

    Disposable Subdermal Needle Electrode, Pt/lr, 12 x 0.40mm, product number TE/S46/638, 25 needles per package, sterile.

    Reason

    Burns of varying degrees can occur to patients with electrodes left in while in the MRI scanner as a result of inadequate safety information in the IFU.

    Code Info

    Lot numbers 044220, exp. 1/1/2023; 045077, exp. 3/1/2023; 045443, exp. 4/1/2023; and 049285, exp. 7/1/2024; UDI-DI 08718375861530.

    Distribution

    US Nationwide distribution in the states of CA, FL, NH, OH, and WA.

    Quantity

    37/25-electrode boxes