Defibtech, LLC: Device Recall
Recall #Z-0505-2025 · 10/14/2024
Class II: Risk
Recall Details
- Recall Number
- Z-0505-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Defibtech, LLC
- Status
- Ongoing
- Date Initiated
- 10/14/2024
- Location
- Guilford, CT, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 22,294 total
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
Product Description
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.)
Distribution Pattern
Ireland
Other Recalls by Defibtech, LLC
- Class II: Risk 03/18/2025
- Class II: Risk 03/18/2025
- Class II: Risk 03/18/2025
- Class II: Risk 03/18/2025
- Class II: Risk 03/18/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.