Reported Dec 4, 2024 · Ongoing

Defibtech DDP-2001: Adult Defibrillation Pads For use with AED Models: Lifeline View Auto, lifeline Pro, lifeline ECG,…

Defibtech, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Defibtech, LLC · 741 Boston Post Rd · Guilford, CT · 06437-2714

Is this the product you have?

  • Defibtech DDP-2001Adult Defibrillation
  • Pads For use with AED ModelsLifeline View Auto, lifeline Pro, lifeline ECG, lifeline View (DDU-2XXX Series). -Indicated for use on victims of sudden cardiac arrest (SCA.)
Lot codes and dates
  • 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
Amount recalled
22,294 total

This recall covers 4 products

The agency filed one notice per product. You are reading one of them; the other 3 are below.

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:35 PM UTC

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