Defibtech, LLC: 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

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

Details from the source

Reason for recall: 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 Distribution: Ireland Quantity: 22,294 total Lot/code info: 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

UPC codes

00815098020454, 10815098020451, 40815098020452

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.