THERANICA BIOELECTRONICS LTD recalls Nerivio Infinity. Model/Catalog Number: FGD000100. Softwar
See all recalls from THERANICA BIOELECTRONICS LTD →Recalled Product
Nerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Version 4.1.2.0, App version 7.28.0.11
Hazard / Issue
Potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor.
Issued by
FDA
Distribution: 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
Lot/Code Info: 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.
✅ What Should You Do?
- 1Contact your healthcare provider immediately to discuss this recall.
- 2Stop using the device if it is safe to do so, and contact your provider.
- 3Follow the manufacturer's remedy instructions provided in the recall notice.
- 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
Looking for a safe alternative?
Search Amazon for Nerivio Infinity. Model/Catalog Number: →If you were harmed by this recalled product, Top Class Actions lists active class action lawsuits and settlements that may apply to you.
Get the next US recall alert before it hits the news.
Free. Weekly digest or instant alerts. Unsubscribe anytime.
CAN-SPAM compliant · No spam · Unsubscribe anytime