Defibtech DDP-100 Adult Defibrillation Pads For use with AED Models: Lifeline and Lifeline Auto ...
FDA Recall #Z-0502-2025 — Class II — October 14, 2024
Product 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 for Recall
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.
Recalling Firm
Defibtech, LLC — Guilford, CT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
22,294 total
Distribution
Ireland
Code Information
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;
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated