FDAMay 3, 2023device
NOxBOXi Nitric Oxide Delivery System, NOXBOX-I, REQNOXBOX-I, Nitric Oxide Delivery Device
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Terminated
Brands named
noxbox
UPCs
5060541640009
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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