Defibtech, LLC: Defibtech DDP-2001: Adult 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.)

Recall number

Z-0504-2025

Recalling firm

Defibtech, LLC

Product

Defibtech DDP-2001: Adult 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.)

Status

Open, Classified

Initiated

2024-10-14

Posted

2024-11-25

Terminated

not on file

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

Root cause

Under Investigation by firm

Action

Defibtech issued Urgent Field Safety Notice on 10/14/24 by e-mail to the Irish Market h via the Distributor Oxygen Care Ltd. titled: Unauthorized Label Applied to Defibtech, LLC's Automated External Defibrillator (AED} Pads within the Irish Market. Letter states reason for recall, health risk and action to take: Actions to be taken by the Customer/User: 1. Check the label of your Defibtech AED Pads. Please review Attachment B which clearly shows authorised labelled Defibtech AED Pads versus unauthorised labelled Defibtech AED Pads. 2. Please confirm receipt of this notice by completing Attachment C "Customer Reply Form", attached to this notice, and return to Oxygen Care, Ltd (our new official Irish Distributor) so that our records may be updated. 3. If an unauthorised label applied to Defibtech AED Pads is confirmed, please urgently return the Defibtech AED Pads along with the completed "Customer Reply Form" to Oxygen Care. Upon receipt of the unauthorized labelled Defibtech AED Pads, Oxygen Care will send a replacement set of authorised labelled Defibtech AED Pads to you at no charge: Oxygen Care Ltd.: Email: Sales@ oxyge n-care.ie Phone: 01 2769700 Address: 2 Holfeld Business Park, Kilmacanogue. Co. Wicklow. Eircode A98 NP27 4. If you have transferred the Defibtech AED Pads to another entity or department, please contact Oxygen Care as per the above contact details. The unauthorised labelled Defibtech AED pads were re-labelled with expiration dates beyond the shelf life of the Defibtech AED Pads. The affected Defibtech AED Pads should not be used. Defibtech will continue to work closely with regulatory authorities toward the resolution of this issue. Defibtech is committed to patient safety and is focused on providing the highest level of customer satisfaction. We appreciate your cooperation and sincerely apologize for any inconvenience this may cause you.

Quantity

22,294 total

Distribution

Ireland

Lot, serial or model codes

UDI-DI: 00815098020447, DDP-2001 adult defibrillation pads, single pack; 30815098020448, DDP-2001 adult defibrillation pads, 10 pairs; 50815098020442, DDP-2001 adult defibrillation pads, 40 pairs

510(k) numbers

not on file

PMA numbers

["P160032"]

Product code

MKJ

Firm FEI

3003521780

Firm city

Guilford

Firm state

CT

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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