BEUDAMED
    FDA Recall 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 · Initiated August 9, 2022

    Recall

    Recall Number
    Z-1737-2022
    Event Number
    90733
    Firm
    Technomed Europe Amerikalaan 71 Maastricht-Airport Netherlands
    FEI Number
    3001450493
    Product Code
    IKT
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    August 9, 2022
    Terminated
    April 11, 2024

    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.

    Action

    The recalling firm issued letters dated 8/9/2022 that were flagged "MRI Safety Information." The letter provided an overview of the issue, the affected devices and lot numbers, a description of the issue including the MRI Safety Information that was added to the Instructions for Use, the hazard, and the actions to be taken. The actions included the consignee is to read the Field Safety Notice, review the list of affected products, inform customers who received or will receive products from the affected lot numbers about the issue by forwarding a copy of the notice and the updated Instructions for Use to them, and complete and sign the enclosed acknowledgment form to indicate they have read the notice, understand its content, and will follow the instructions as intended. The form is to be returned via email.

    Distribution

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

    Quantity

    37/25-electrode boxes