Reported Nov 8, 2023 · Ongoing
Coapt Dome Electrode, Gen2 system, cutaneous electrode
Coapt 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: Coapt LLC · 303 W Institute Pl Ste 200 · Chicago, IL · 60610-3080
Is this the product you have?
- Coapt Dome Electrode, Gen2 system, cutaneous electrode
- Lot codes and dates
UDI/DI +B618E0/$+201907E00256Ball Gen2 system serial number
- Amount recalled
- 247 devices
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Patient may experience minor burn or blistering if device is exposed to direct sunlight and/or warm temperatures for over 12 hours or battery is damaged.
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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