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NOxBOX Ltd. Recalls NOxBOXi Nitric Oxide System for Manifold Failure that May Cause Gas Leaks and Interrupt Therapy to Neonates
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 on 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.
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries, serious health consequences, or death.
Questions?
Customers with questions about this recall should contact their sales representative or customer service at 833-NOX-VENT.
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