Mallinckrodt, LLC. recalls INOmax DSIR -(delivery system) delivers INOMAX (nitric oxide for inhalation) therapy gas into the inspiratory limb of t…

Recall date

June 23, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1745-2022

FDA classification

Class II

Brand / firm

Mallinckrodt, LLC.

Sold / distributed

Foreign Only: Argentina Australia Austria Beligum Canada Chile Columbia Czech Republic Denmark Ecuador Estonia Finland France Germany Great Britain Hungary Iceland Ireland Italy Latvia Mexico Netherlands Norway Poland Portugal Romania Slovakia South Africa Spain Sweden Switzerland UAE Uruguay

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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