NOXBOX LTD Recall: NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
NOXBOX LTD Recall: NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: NOXBOX LTD; Product: NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I; Reason for recall: Fluctuations may be more likely to occur if the total
| Recalling firm | NOXBOX LTD |
|---|---|
| Product | NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I |
| Reason for recall | Fluctuations may be more likely to occur if the total flow through the device sensor (used by the device to determine flow) is less than the minimum device requirement of 0.5 LPM. In addition, dose fluctuations have been observed when Bunnel LifePulse HFJV system or conventional ventilators have the following device settings: low service pressures generally less than 3.0 PSI, a pressure difference greater than 5.0cm H2O; or at breath per minute rates of 300 (5 Hz). |
| Classification | Class I (most serious — reasonable probability of serious health consequences or death) |
| Status | Ongoing |
| Distribution | Domestic: TN |
| Recall initiated | 20250909 |
| Recall number | Z-0028-2026 |
| Category | device |
| Country | United Kingdom |
$29/mo
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