Beyond Air Inc.: No Calibration Gas Cylinder, 45ppm; Model/catalog Number: 80006; Software Version: N/a - No Firmware/software; Product Description: Nitric Oxide Ca...
- Recalling firm
- Beyond Air Inc.
- Product
- NO Calibration Gas Cylinder, 45ppm; Model/Catalog Number: 80006; Software Version: N/A - No firmware/software; Product Description: Nitric Oxide Calibration Gas, 45 ppm Intended to be used with LungFit PH device (FDA PMA 200044) during pre verification checks and monthly maintenance to calibration internal NO sensors. Component: No;
- Reason
- Some NO calibration tanks may have been contaminated with O2 (from the air).
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-10-20
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide - US Nationwide distribution in the states of California, Tennessee, Arkansas, Nebraska, New York, North Carolina, Delaware, New Jersey, Texas, Indiana, Minnesota, Illinois, Oklahoma, Georgia, Florida, Utah and the countries of Canada, Hong Kong, Australia, Manila, Vietnam, Israel,...
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/74090c10-e717-44d2-bdbe-6f9c7bda56ab