NOxBOX Ltd. Recalls NOxBOXi Nitric Oxide System for Manifold Failure that May Cause Gas Leaks and Interrupt Therapy to Neonates

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

The NOxBOXi Nitric Oxide Delivery System (NOxBOXi) delivers a constant concentration of nitric oxide (NO) medical gas for inhaled nitric oxide therapy through the ventilator that provides breathing support to the patient. The system can also monitor nitric oxide, nitrogen dioxide, and oxygen levels while the patient receives NO therapy. It is approved for use in newborns, or neonates, including those with congenital heart disease.

NOxBOX Ltd. is recalling NOxBOXi Nitric Oxide Delivery Systems due to a misalignment of the check valve in the device’s manifold, which may cause the manifold to fail. If it fails, nitric oxide or oxygen may leak out. The device may also change gas cylinders earlier than expected or not at all.

This issue may lead to interrupted nitric oxide therapy, causing a drop in blood oxygen levels (desaturation) or increased pressure in the artery that carries oxygen from the heart to the lungs (pulmonary artery) which may pose even greater risks to neonates with congenital heart disease. Use of affected devices could lead to serious injury or death in an already fragile patient population.

NOxBOX Ltd. reports no injuries and no deaths related to this issue.

On May 2, 2023, NOxBOX Ltd. sent affected customers an Urgent Medical Device Recall letter with the following recommended actions:

NOxBOX Ltd. is working to obtain new manifolds and, once these are available, will correct or replace affected devices on a rolling basis.

Customers with questions about this recall should contact their sales representative or customer service at 833-NOX-VENT.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using the online form or call 1-800-332-1088 for more information on how to mail or fax the form.

07/13/2023