Defibtech, LLC: Medical Device Recall in 2024 - (Recall #: Z-0503-2025)
See the recall detail below. You can also see other recalls from the same firm in 2024.
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.)
Class II
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
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
Ireland
Voluntary: Firm initiated