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.

Recalled Product

• Product Names: NOxBOXi Nitric Oxide Delivery System
• Product Serial Numbers: See Recall Database Entry
• Distribution Dates: May 21, 2021 to February 27, 2023
• Devices Recalled in the U.S.: 767
• Date Initiated by Firm: May 3, 2023

Device Use

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.

Reason for Recall

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.

Who May be Affected

• Neonates who receive inhaled nitric oxide therapy using the NOxBOXi Nitric Oxide Delivery System.
• Health care providers who support patients receiving inhaled nitric oxide therapy including the NOxBOXi Nitric Oxide Delivery System.

What to Do

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

• Check device inventory and any devices presently being used to identify any affected NOxBOXi devices.
• Affected NOxBOXi devices do not need to be removed from service unless the device does not pass the start-up high-pressure leak test or it alarms during cylinder changeover and troubleshooting does not resolve the alarms.
• Ensure all relevant personnel are instructed on the current troubleshooting measures as described in the letter:
  • When initiating therapy on a new patient, prioritize use of a device that is not affected if available.
  • If the only available device for use is an affected device or if an affected device is already in use:
    • Ensure that a back-up device and back-up cylinders are available during start up and cylinder changeover to mitigate the potential risk of an interruption or delay in therapy.
    • Ensure that two cylinders are connected to the NOxBOXi device, as recommended through training and in the instructions for use.
    • Do not use the device with only one cylinder.
    • When setting up devices for therapy, ensure that all leak check procedures are followed per the on-screen set up guide, the instructions for use Section 4.4.1 NO Gas Cylinder Connection, and the start-up high-pressure leak test.
    • If a manifold check valve malfunctions during start up, the device will not pass the start-up supply high-pressure leak test.
    • If a manifold check valve malfunctions during cylinder changeover, the device will present one of the following alarms:
      • Low cylinder audible and visual alarms
      • If not addressed, then cylinder critical audible and visual alarms.
    • If one of the above alarms occurs, follow all on-screen troubleshooting instructions, including potentially replacing the NO cylinder.
    • If the troubleshooting steps do not resolve the issue, switch to a back-up device and return the impacted device for inspection and correction, if needed.
    • In some cases, the device may use both cylinders at the same time, instead of sequentially, which may result in both cylinders depleting at the same time or change over from one NO supply cylinder to the other earlier than expected.
  • Report any known adverse events to Linde Gas & Equipment Inc. (LGE), your device supplier, who will work with NOxBOX Ltd. to assess whether they are related to this recall.
• If affected devices are found, complete and return the response form enclosed with the letter as soon as possible.

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

Contact Information

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

Additional Resources:

• Medical Device Recall Database Entry

How do I report a problem?

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.

Read the full alert.