Noxboxi Nitric Oxide Monitor And Delivery System
- Recalling firm
- Keyport Ltd
- Product
- NOXBOXi Nitric Oxide Monitor and Delivery System. [Device]. Model: NOxBOXi Intelligent Delivery and Monitor. Affected: Product code: NOXBOX-1
- Reason
- The manufacturer has identified an increased trend in complaints for oxygen leaks within the NOxMixer module of the NOxBOXi device due to failure of the tubing or tubing connection. The NOxMixer module is intended to deliver a continuous flow of nitric oxide (NO), mixed in line with oxygen (O2) for emergency applications and when manually ventilating a patient (i.e., during Emergency and Manual Bagging modes). This failure occurs inside the NOxMixer module when a leak develops in the internal oxygen tubing or the tubing connection at the elbow fitting upstream of the oxygen flowmeter.
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-08-31
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/8737c5ab-cbbf-4668-b22e-3a22235108a8