The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1745-2022·Announced 2022-09-21

INOmax DSIR Delivery System incompatible with upgraded Leoni Plus ventilator

The INOmax DSIR nitric oxide delivery system is incompatible with the 2021-upgraded Leoni Plus ventilator. Without proper connection including a required one-way valve, patients may receive excessive nitric oxide.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This Class II medical device recall involves a real incompatibility that could result in excessive nitric oxide delivery if used improperly. No illnesses, injuries, or deaths have been reported. The hazard is contingent on improper use without the specified one-way valve, making the harm theoretical rather than documented. Per the rubric, risk-of-harm products where injury has not yet been reported score 3 (High).

Plain-English summary

The INOmax DSIR Delivery System (Model 10007) is a medical device manufactured by Mallinckrodt, LLC that delivers nitric oxide therapy gas into the breathing circuit of ventilators to provide a controlled concentration of nitric oxide for patients requiring this therapy.

The device is not compatible with the Leoni Plus ventilator following its 2021 upgrade by Lowenstein Medical, which included new hardware and software. The upgraded ventilator cannot be properly connected to the INOmax DSIR as instructed in the device's Operators Manual. The manual specifically requires the use of a one-way valve when using the device with the Leoni Plus ventilator during High Frequency Oscillatory Ventilation mode.

Use of the device without the required one-way valve may result in delivery of excessive nitric oxide (NO) to the patient. This incompatibility poses a risk of improper gas delivery and potential patient harm.

The recall affects 4,225 units distributed outside the United States. Healthcare facilities and clinicians using these devices should verify ventilator compatibility and ensure all required safety procedures, including use of the one-way valve specified in the device manual, are properly followed.

The recalled product

Product
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 Number: 10007
Manufacturer
Mallinckrodt, LLC.
Category
Medical Device — Nitric Oxide Delivery System
Hazard
Affected units
4,225

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All serial numbers

Distribution

Distribution scope not specified by the agency.

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