FDA

The Mallinckrodt Manufacturing, LLC One-Way Valve, 22F x 22M is part of the INOmax Delivery System, which delivers nitric oxide (INOmax) therapy gas into the tubes between the ventilator and patient airway (breathing circuit). The One-Way Valve is used to prevent backward flow of nitric oxide gas into the INOmax DSIR injector module. The omission of One-Way Valve can also result in high nitric oxide delivery to the patient. The intended prevention of the backward flow and higher than prescribed drug delivery applies to both high frequency ventilators and spontaneous mask setup.

Reason for Recall: Mallinckrodt is recalling its One-Way Valve, 22F x 22M due to devices not opening properly, which prevents or reduces the flow of ventilated air or oxygen.

For more information, visit:  https://www.fda.gov/medical-devices/medical-device-recalls/mallinckrodt-manufacturing-llc-recalls-one-way-valve-22f-x-22m-not-opening-properly?utm_medium=email&utm_source=govdelivery