FDA-Device2025-10-15Class I

NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I

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Hazard

Fluctuations may be more likely to occur if the total flow through the device sensor (used by the device to determine flow) is less than the minimum device requirement of 0.5 LPM. In addition, dose fluctuations have been observed when Bunnel LifePulse HFJV system or conventional ventilators have the following device settings: low service pressures generally less than 3.0 PSI, a pressure difference greater than 5.0cm H2O; or at breath per minute rates of 300 (5 Hz).

Sold states
Domestic: TN
Affected count
1667 units
Manufactured in
Unit 1, Eurolink Gateway; Castle Road, Sittingbourne, United Kingdom
Products
NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0028-2026

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