FDA Device recall Z-0505-2025
Defibtech DDP-2002: Pediatric Defibrillation Pads For use with AED Models: Lifeline View Auto, lifeline Pro, Lifeline ECG, Lifeline View (D…
- FDA Device
- Class II
- ongoing
- Published 2024-12-04
On 2024-12-04 the FDA classified a Class II recall of Defibtech DDP-2002: Pediatric Defibrillation Pads For use with AED Models: Lifeline View Auto, lifeline Pro, Lifeline ECG, Lifeline View (D… by Defibtech, citing 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 a….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0505-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-10-14 |
| Published | 2024-12-04 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Defibtech |
| Distribution | n/a |
Product
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.)
Reason
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
Identifiers
| code_info | UDI-DI: 00815098020454, DDP-2002, pediatric defibrillation pads, single pair; 10815098020451, DDP-2002, pediatric defib…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0505-2025%22
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