Defibtech DDP-100 Adult Defibrillation Pads For use with AED Models: Lifeline and Lifeline Auto (DDU-1:XX Series)- Indi
Summary
The FDA issued a Class II for Defibtech DDP-100 Adult Defibrillation Pads For use with AED Models: Lifeline an by Defibtech, LLC. Reason: 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 au.
Details
Source
Device Recall
External ID
Z-0502-2025
Action Date
2024-12-04
Status
Ongoing
Category
device
Product Description
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)
Lot/Code Info: UDI-DI: 00815098020423, DDP-100 adult defibrillation pads, single configuration; 30815098020424, DDP-100 adult defibrillation pads, 10 pairs; 50815098020428, DDP-100 adult defibrillation pads, 40 pairs;
Quantity Affected: 22,294 total
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
Type: Voluntary: Firm initiated
Recall Initiated: 2024-10-14
Company
Guilford, CT
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 162 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Defibtech, LLC has 12 FDA actions in our database, including 11 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Defibtech, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Defibtech, LLC have FDA actions?
Defibtech, LLC has 12 FDA actions in our database, including 11 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0502-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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