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FDAFDA · Food and drugs·Recall number Z-0505-2025

Defibtech DDP-2002: Pediatric Defibrillation Pads For use with AED Models: Lifeline View Auto, lifeline Pro, Lifeline ECG, Lifeline View (DDU-2XXX Series -Indicated for use on victims of sudden cardiac arrest (SCA.)

Published December 4, 2024 · Recall initiated: October 14, 2024

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Within the Irish Market, that 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 potentially 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

What to do

Voluntary: Firm initiated · E-Mail

Recall details

Manufacturer
Defibtech, LLC
Distributor
Ireland
Lot
UDI-DI: 00815098020454, DDP-2002, pediatric defibrillation pads, single pair; 10815098020451, DDP-2002, pediatric defibrillation pads, single pair configuration; 40815098020452, DDP-2002, pediatric defibrillation pads, 20 pairs
Risk classification
Class II
Area (FDA)
device
Country
United States

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