Reported Jun 21, 2023 · Terminated
NOxBOXi Nitric Oxide Delivery System, NOXBOX-I, REQNOXBOX-I, Nitric Oxide Delivery Device
Noxbox Ltd.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: NOXBOX LTD · Unit 1080 · Sittingbourne, N/A · N/A
Is this the product you have?
- NOxBOXi Nitric Oxide Delivery System, NOXBOX-I, REQNOXBOX-I, Nitric Oxide Delivery Device
- Lot codes and dates
- UDI/DI5060541640009
- Serial Numbers distributed in US
493 of 493 codes
NI101029NI102476NI102518NI102560NI102594NI102629NI101388NI102477NI102519NI102561NI102595NI102630NI101392NI102478NI102520NI102562NI102596NI102631NI101441NI102479NI102522NI102563NI102597NI102632NI101562NI102480NI102525NI102564NI102598NI102633NI101679NI102481NI102528NI102565NI102599NI102634NI101703NI102482NI102530NI102567NI102600NI102635NI101760NI102483NI102531NI102569NI102601NI102636NI101806NI102484NI102535NI102571NI102602NI102637NI101881NI102485NI102537NI102573NI102604NI102639
- Amount recalled
- 548 (US); 208 (OUS)
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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