Mallinckrodt recalls INOmax DSIR delivery systems that may not work with newer Leoni Plus ventilators, risking high nitric oxide delivery. Affected units require specific valve use as per manual.
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.
Mallinckrodt is recalling INOmax DSIR delivery systems that may not connect properly with newer Leoni Plus ventilators. This could lead to unsafe nitric oxide levels if the one-way valve isn't used as instructed.
The INOmax DSIR requires a one-way valve when connected to Leoni Plus ventilators in High Frequency Oscillatory Ventilation mode. Without this valve, the system may deliver high levels of nitric oxide, which can be harmful to patients.
Patients using the INOmax DSIR delivery system with Leoni Plus ventilators upgraded in 2021 are most at risk. Healthcare providers who use these devices for nitric oxide therapy should check compatibility.
The INOmax DSIR delivery system has model number 10007 and all serial numbers. It was sold with Leoni Plus ventilators upgraded by Lowenstein Medical in 2021.
Ensure the one-way valve is installed as per the INOmax DSIR Operators Manual when using with Leoni Plus ventilators.
The INOmax DSIR delivery system is not compatible with the upgraded Leoni Plus ventilators from 2021, which may cause unsafe nitric oxide delivery without the one-way valve.
No, but you must ensure the one-way valve is installed as per the manual to avoid high nitric oxide delivery.
The recall does not require discarding the device, but you must use the one-way valve as instructed to prevent unsafe nitric oxide levels.
We’ve drafted a message you can send Mallinckrodt to request your refund or repair — edit it as you like.
Subject: Recall Z-1745-2022 — Mallinckrodt Mallinckrodt Hello, I own a Mallinckrodt that is covered by recall Z-1745-2022 from Mallinckrodt. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
