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INOmax
Mallinckrodt Manufacturing LLC · Model 90844 · UDI-DI 00810055288441
MRN
Prescription
10
510(k) clearances
2,049
Adverse events (30 deaths)
16
Recalls
11
Facilities
Description
CELL, NO FUEL
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-09-09 | NOXBOX LTD | The unexpected internal fault / system diagnostic error to result when a rapid succession of button selections is made to the user interface without waiting for the device to respo |
| 2025-09-09 | NOXBOX LTD | 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. |
| 2023-11-17 | Vero Biotech, LLC | Cassette did not meet an 1n-process flow criterion. |
| 2023-07-19 | NOXBOX LTD | Replacement of the internal Sample Pump due to high failure rates. |
| 2023-05-03 | NOXBOX LTD | 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 cy |
| 2022-06-23 | Mallinckrodt, LLC. | The INOmax DSIR Delivery System, manufactured by Mallinckrodt Pharmaceuticals, is not compatible with the upgraded version of the Leoni Plus ventilator, manufactured by Lowenstein |
| 2021-09-09 | Vero Biotech, LLC | Manufacturing defect involving reversal of the inlet and outlet gas lines, resulting in delivery of nitrogen dioxide (NO2) instead of nitric oxide (NO). |
| 2021-05-19 | Vero Biotech, LLC | Reports received of NO measured below desired dose during transition between primary console and backup console since Software Version 2.2.3 was uploaded to consoles in the field. |
| 2018-07-09 | INO therapeutics LLC/dba ikaria | INOmeters affixed to the INOflo cylinders in Lot 17FP-0570 were programmed with an incorrect expiration date (11/2017). For Lot 17FP-0570, the label affixed to each INOflo cylinde |
| 2016-11-21 | INO Therapeutics (dba Ikaria) | Mallinckrodt discovered that some devices may have been manufactured with an out-of-tolerance manometer which can result in in an inaccurate proportional valve calibration table in |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.