Recall Z-0504-2025 ยท MKJ Automated External Defibrillators (Non-Wearable)
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.)
| Date | Nov 25, 2024 (initiated Oct 14, 2024) |
| Status | Open, Classified |
| 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 Atta |
| Quantity | 22,294 total |
| Distribution | Ireland |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.