INOmax DSIR -(delivery system) delivers INOMAX (nitric oxide for inhalation) therapy gas into the inspiratory limb of th

FDA device recall Z-1745-2022 · posted 2022-09-13 · Open, Classified

Recall details

Recalling firm

Mallinckrodt, LLC.

Reason for recall

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.

Action taken

Mallinkrodt issued via email on 6/23/22 an Urgent Field Safety Notice (FA-R-0023) stating reason for recall, health risk and action to take: Upon receipt of this Field Safety Notice (FSN), INOmax DSIR operators are advised not to use an upgraded Leoni Plus ventilator with the INOmax DSIR. The INOmax DSIR Validated Ventilator List, supplied as Technical Bulletin TB-20005, will be revised to remove the Leoni Plus ventilator and distributed as soon as it is available. A response form is required for this FSN. Please complete the attached form and return as instructed.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

MRN

Quantity affected

4,225 units OUS

Distribution

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 Netherla

Date initiated

2022-06-23

Date posted

2022-09-13

Location

Bedminster, NJ

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