BEUDAMED
    FDA Enforcement Class II Ongoing

    TENSIVE Conductive Adhesive Gel, REF 016-401600

    Recall: Z-1305-2024 · Reported March 27, 2024

    Enforcement

    Recall Number
    Z-1305-2024
    Event ID
    93969
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Natus Neurology Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 27, 2024
    Initiation Date
    February 7, 2024
    Classification Date
    March 19, 2024
    Address
    3150 Pleasant View Rd, Middleton, WI, 53562-4800, United States

    Description

    TENSIVE Conductive Adhesive Gel, REF 016-401600

    Reason

    Natus has become aware that its third-party supplier Parker Laboratories Inc. is conducting a voluntary recall related to their Tensive Conductive Adhesive Gel, Ref. 22-60 Lot Number A0623009. They have received five complaints. These customers reported that the gel is too thick, is discolored (darker than usual), and in one instance, patients reported irritation after procedures using the gel.

    Code Info

    UDI/DI 00855683006333, Lot Numbers: A0623009

    Distribution

    Worldwide distribution - US Nationwide and the country of Canada.

    Quantity

    80 units