FDA recall Z-0502-2025

Defibtech, LLC · Class II · device

Product

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.

Distribution

Ireland

Key facts

Status
Ongoing
Initiation date
2024-10-14
Report date
2024-12-04
Voluntary/Mandated
Voluntary: Firm initiated
Location
Guilford, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0502-2025