Bedminster, NJ, United States
Mallinckrodt, LLC. recalls
1 recall recorded since 2018, most recently on 23 June 2022. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 23 June 2022
- Reason
- 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.
- 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 Netherlands Norway Poland Portugal Romania Slovakia South Africa Spain Sweden Switzerland UAE Uruguay
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1745-2022
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.