BEUDAMED
    FDA Enforcement Class II Terminated

    Ad-Tech Lightweight CABRIO Cable - Product Usage: Designed for the purpose of connecting these electrodes to third party monitors/stimulators.

    Recall: Z-2494-2021 · Reported September 29, 2021

    Enforcement

    Recall Number
    Z-2494-2021
    Event ID
    88590
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ad-Tech Medical Instrument Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 29, 2021
    Initiation Date
    August 9, 2021
    Classification Date
    September 20, 2021
    Termination Date
    January 13, 2023
    Address
    400 W Oakview Pkwy, Oak Creek, WI, 53154-7213, United States

    Description

    Ad-Tech Lightweight CABRIO Cable - Product Usage: Designed for the purpose of connecting these electrodes to third party monitors/stimulators.

    Reason

    Incorrect version of labels were used.

    Code Info

    Item Code & Lot #: L-SRL-10DIN Lot #'s 120340, 122140 and 124140; L-SRL-10DIN-84 Lot #'s 126270 and 127270; L-SRL-12BDIN Lot # 125250; L-SRL-16BDINLot #124150; L-SRL-20DINLot # 127060; L-SRL-32BDIN Lot # 126070 L-SRL-4DIN Lot #'s 123050, 129150 and 120250; L-SRL-64BDIN Lot #127270; L-SRL-6DINLot #'s 128060 and 120160; L-SRL-8DIN Lot #'s 128150 and 124050; L-SRL-8DIN-11 Lot # 125170

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of DC, FL, MI, NY, PA and TX and the countries of Spain, France, Italy, Greece, Great Britain and Canada.

    Quantity

    69