BEUDAMED
    FDA Enforcement Class II Ongoing

    Defibtech DDP-100 Adult Defibrillation Pads For use with AED Models: Lifeline and Lifeline Auto (DDU-1:XX Series)- Indicated for use on victims of sudden cardiac arrest (SCA)

    Recall: Z-0502-2025 · Reported December 4, 2024

    Enforcement

    Recall Number
    Z-0502-2025
    Event ID
    95594
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Defibtech, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 4, 2024
    Initiation Date
    October 14, 2024
    Classification Date
    November 21, 2024
    Address
    741 Boston Post Rd, Suite 201, Guilford, CT, 06437-2714, United States

    Description

    Defibtech DDP-100 Adult Defibrillation Pads For use with AED Models: Lifeline and Lifeline Auto (DDU-1:XX Series)- Indicated for use on victims of sudden cardiac arrest (SCA)

    Reason

    Within the Irish Market, a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the authorized label removed and an unauthorized label applied, could lead to expired Defibtech AED Pads appearing as though they are within the acceptable shelf life. There is a possibility of hydrogel drying, which may result in poor electrical connection to the patient, which can reduce the energy delivered to the patient.

    Code Info

    UDI-DI: 00815098020423, DDP-100 adult defibrillation pads, single configuration; 30815098020424, DDP-100 adult defibrillation pads, 10 pairs; 50815098020428, DDP-100 adult defibrillation pads, 40 pairs;

    Distribution

    Ireland

    Quantity

    22,294 total