Reported Sep 21, 2022 · Ongoing
INOmax DSIR -(delivery system) delivers INOMAX (nitric oxide for inhalation) therapy gas into the inspiratory limb of…
Mallinckrodt, LLC.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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: Mallinckrodt, LLC. · 1425 Us Highway 206 · Bedminster, NJ · 07921-2653
Is this the product you have?
- INOmax DSIR -(delivery system) delivers INOMAX (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user
- Model Number10007
- Lot codes and dates
- All serial numbers
- Amount recalled
- 4,225 units OUS
Why it was recalled
The INOmax DSIR Delivery System, manufactured by Mallinckrodt Pharmaceuticals, is not compatible with the upgraded version of the Leoni Plus ventilator, manufactured by Lowenstein Medical. The Leoni Plus ventilator was recently upgraded in 2021 by Lowenstein Medical, with new hardware and software, and the upgraded version cannot be appropriately connected with the INOmax DSIR as instructed in the INOmax DSIR Operators Manual (OM). The INOmax DSIR OM requires the use of a one-way valve with the Leoni Plus ventilator during High Frequency Oscillatory Ventilation mode and warns that use of the device without a one-way valve may result in high Nitric Oxide (NO) delivery.
This product could cause temporary or reversible health problems — stop using it.
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