Beyond Air NO calibration gas recalled for possible O2 contamination
Beyond Air is recalling 181 cylinders of 45 ppm nitric oxide calibration gas used with the LungFit PH device. Some cylinders may have been contaminated with oxygen from the air. The notice reports no injuries.
From the FDA notice · Read the official notice ↗
What to do
- Set aside affected cylinders and do not use them to calibrate the LungFit PH internal NO sensors.
- Check each cylinder number against the notice's list. The product is model 80006, product code 8006, Mesa Gas part Z166045.
- Contact Beyond Air about the recall. The notice does not specify a remedy, refund or replacement.
Is yours affected?
Compare your label or packaging with the recalled product.
- 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;
- Sold in
- Nationwide
- Made for
- All ages (under 100 years)
Details
- Units affected
- 181
- Illnesses reported
- None reported
- Manufactured in
- 900 Stewart Ave, Ste 301, Garden City, New York, United States
- Classification
- Class II
- Recall number
- Z-0436-2027
In the FDA's words
- Description
- 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; Some NO calibration tanks may have been contaminated with O2 (from the air). The Beyond Air product code is 8006; Mesa Gas part number is: Z166045; UDI-DI: N/A; Cylinder Numbers: C418368, C547918, C385448, C249243, C391758, C391775, C418404, C385315, C418603, C418303, C418750, C391573, C385388, C391749, C418707, C391651, C548078, C418298, C385354, C385373, C391773, C391805, C418606, C418313, C418346, C418720, C391819, C391910, C547921, C391636, C391820, C391907, C547912, C547896, C391928, C548077, C385314, C418675, C385425, C548059, C391911, C391800, C418676, C548069, C548034, C547980, C391745, C391801, C391772, C418627, C418427, C418406, C418376, C418663, C391752, C418677, C391703, C141887, C385130, C391762, C418698, C385372, C385440, C547891, C385337, C385353, C418684, C385441, C391803, C391767, C547881, C418390, C385385, C391717, C418494, C391757, C418349, C418751, C391886, C391701, C418296, C418291, C418685, C391724, C391864, C391927, C385142, C385331, C385131, C391768, C391779, C391614, C418514, C418403, C418353, C418604, C418742, C391885, C547934, C547894, C547933, C547908, C547885, C385358, C418607, C391750, C391780, C391753, C391751, C391740, C391746, C391571, C418686, C418697, C418708, C418719, C418314, C418355, C418743, C418741, C418678, C548057, C548075, C548068, C548061, C548056, C548063, C548074, C548066, C548064; 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, Taiwan, Panama, Singapore. Affected quantity: 181
- Hazard
- Some NO calibration tanks may have been contaminated with O2 (from the air).