The FDA labels NOxBOXi device as a Class I recall, the most dangerous level due to the risk of serious injury and death. Credit: JHVEPhoto/Shutterstock

UK based provider of medical devices for nitric oxide therapy, NOxBOX, has issued an urgent recall of its NOxBOXi nitric oxide system.

Following the recall order, the US Food and Drug Administration (FDA) recognised the recall of the NOxBOXi device as a Class I recall, the most dangerous level due to the risk of serious injury and death.

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The recall order was issued after it was discovered that there was a misalignment of the check valve in the device’s manifold. The error could cause the manifold to break letting nitric oxide or oxygen leak out. This failure could interrupt nitric oxide therapy causing a desaturation of blood oxygen levels and increase pressure on the pulmonary artery.

Neonates (newborns) with congenital heart diseases are at risk if they use this device and it could cause serious injury or death to patients. Also, the devices gas cylinders my fail to change or switch earlier than expected.

Despite the recall, NOxBOX has reported no deaths or injuries have been caused from this issue.

The NOxBOXi device was designed to supply a constant concentration of nitric oxide medical gas used in inhaled nitric oxide therapy through a ventilator that delivers breathing support to the patient. It also has the built-in capability to monitor oxygen, nitric oxide, and nitrogen dioxide levels at the same time.

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Originally it was approved to be used for neonates at risk of congenital heart disease.

For those affected by the malfunction, the NOxBOXi device does not need to be taken out of service. According to the Urgent Medical Device Recall letter from NOxBOX, the device should only be removed if it does not pass the start-up high-pressure leak test, or it alarms during cylinder changeover and troubleshooting does not resolve the alarms.

Currently the company is working to replace the manifold on affected devices on a rolling basis.

In 2016 Linde Inc (Linde) formerly known as Praxair Inc acquired NOxBOX to expand its offerings to hospitals and deliver the latest technology in respiratory healthcare.