United StatesNOxBOXi Nitric Oxide Delivery System (Model NOXBOX-I; also distributed as REQNOXBOXI; UDI-DI 05060541640009; all serial numbers) sold in TN (1667 units) is being recalled by Noxbox LTD. The device may experience nitric oxide dose or flow fluctuations when total flow through the device sensor is below 0.5 LPM, and dose fluctuations have been observed with the Bunnel LifePulse HFJV system or conventional ventilators set with low service pressures generally less than 3.0 PSI, a pressure difference greater than 5.0 cm H2O, or at breath rates of 300 (5 Hz).
What's being recalled
NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
Recalling firm: Noxbox LTD, Sittingbourne, United Kingdom.
How to identify it
Model Numbers: (1) NOXBOXI (NBL (Manufacturer)), (2) REQNOXBOXI (Linde (U.S. Distributor)); UDI-DI: 05060541640009; All serial numbers.
The 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).
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
Domestic: TN
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)