United StatesNerivio Infinity devices (Model/Catalog FGD000100) with firmware FW Version 4.1.2.0 and app version 7.28.0.11 — identified by UDI 01072900175781181125120221NI2544-0300673, GTIN 7290017578118 and serial NI2544-0300673 — are being recalled. The devices were recalled because the battery could experience a thermal-runaway event during charging, which may produce smoke and odor.
What's being recalled
Nerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Version 4.1.2.0, App version 7.28.0.11
Recalling firm: Theranica Bioelectronics LTD, Netanya, Israel.
How to identify it
Model/Catalog Number: FGD000100. UDI: 01072900175781181125120221NI2544-0300673 Software Version: FW Version 4.1.2.0, App version 7.28.0.11 GTIN: 7290017578118. Serial Number: NI2544-0300673.
The hazard
Potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
The product's entry point to the US is a 3PL warehouse from which it is being shipped to DME distributors or specialty pharmacy who perform the shipment to the end-user
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)