BEUDAMED
    FDA Recall Open, Classified

    TENSIVE Conductive Adhesive Gel, REF 016-401600

    Recall: Z-1305-2024 · Initiated February 7, 2024

    Recall

    Recall Number
    Z-1305-2024
    Event Number
    93969
    Firm
    Natus Neurology Inc
    FEI Number
    3010611950
    Product Code
    GYB
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    February 7, 2024
    Posted
    March 19, 2024
    Address
    3150 Pleasant View Rd, Middleton, WI, 53562-4800

    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.

    Action

    Natus issued an Urgent Medical Device Recall Notice to its consignees on 02/07/2024 via UPS and email. The notice explained the issue and risk to health. It also requested the consignee cease use, complete and return the form for the replacement of the product.

    Distribution

    Worldwide distribution - US Nationwide and the country of Canada.

    Quantity

    80 units