FDA Medical devices recall · December 4, 2024

Defibtech DDP-200P: Pediatric Defibrillation Pads 0 For use with AED… recall

Read the official FDA notice ↗

Product

Defibtech DDP-200P: Pediatric Defibrillation Pads 0 For use with AED Models: Lifeline and Lifeline Auto (DDU-l XX Series)-Indicated for use on victims of sudden cardiac arrest (SCA.)

Why was it recalled?

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 should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

UDI-DI: 00815098020430, DDP-200P pediatric defibrillation pads, single pair; 10815098020437, DDP-200P pediatric defibrillation pads, single pair configuration; 40815098020438, DDP-200P pediatric defibrillation pads, 20 pairs

Distribution

Ireland

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (medical devices), recall Z-0503-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.