FDA-Device2023-06-21Class I
NOxBOXi Nitric Oxide Delivery System, NOXBOX-I, REQNOXBOX-I, Nitric Oxide Delivery Device
NOXBOX LTD
Hazard
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.
Sold states
Worldwide distribution - US Nationwide and the countries of Bahrain, Bolivia, Brazil, Ecuador, Finland, France, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Panama, Saudi Arabia, Singapore, South Africa, Spain, Taiwan, Turkey, UAE, United Kingdom.
Affected count
548 (US); 208 (OUS)
Manufactured in
Unit 1080, &; 1081 Galley Drive; Kent Science Park, Sittingbourne, N/A, United Kingdom
Products
NOxBOXi Nitric Oxide Delivery System, NOXBOX-I, REQNOXBOX-I, Nitric Oxide Delivery Device
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1667-2023Don't want to check this manually?
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