FDA updates instructions for NOxBOXi nitric oxide delivery system after leak risk identified

The FDA has issued a correction for the NOxBOXi nitric oxide delivery system with the NOxMixer module after discovering that the device can leak oxygen during inhaled nitric oxide therapy.

The agency says the leak could cause temporary or reversible health problems and, although unlikely, could lead to serious issues. The correction does not require removal of the devices from service.

NOxBOX sent a letter to affected customers on August 19 advising them to review and follow updated pre-use inspection instructions, ensure a tight connection at the oxygen inlet, and complete all system checks before use.

Devices that pass the pre-use checks may continue to be used in critical and emergency situations. If a device fails the checks, it should be taken out of service.