NOxBOXi Nitric Oxide Delivery System, NOXBOX-I, REQNOXBOX-I, Nitric Oxide Delivery Device

FDA device recall Z-1667-2023 · posted 2023-06-09 · Terminated

Recall details

Recalling firm

NOXBOX LTD

Reason for recall

Device may experience malfunctions due to misalignment of the check valve in the manifold. If the device fails, there is a risk of nitric oxide leak, oxygen gas leak, or earlier cylinder gas changeover than expected or not at all. In a worst case scenario, there may be an interruption in therapy which could lead to oxygen desaturation of the patient and associated complications.

Action taken

On May 3, 2023, the firm notified customers via URGENT MEDICAL DEVICE RECALL letters. Devices do not need to be removed from service unless they do not pass the start-up high-pressure leak test or it alarms during cylinder changeover and troubleshooting does not resolve the alarms. Customers should prioritize use of a device that is not affected, if available, when initiating therapy on a new patient. If there are no unaffected devices available, or if an affected device is already in use on a patient, follow troubleshooting measures as provided in the letter. Once new manifolds are available, NBL will correct or replace affected devices on a rolling basis. If you have any questions or require further assistance, please contact your sales representative or customer service at 833-NOX-VENT.

Root cause

Component change control

Status

Terminated

Product code

MRN

Quantity affected

548 (US); 208 (OUS)

Distribution

Worldwide distribution - US Nationwide and the countries of Bahrain, Bolivia, Brazil, Ecuador, Finland, France, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Kuwait, Malaysia, Mexico, Netherlan

Date initiated

2023-05-03

Date posted

2023-06-09

Date terminated

2024-10-31

Location

Sittingbourne, United Kingdom

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