September 13, 2023

FDA: Class I recall of Mallinckrodt One-Way Valve, 22F x 22M

Editor's Note

The Food and Drug Administration (FDA), on September 12, identified the recall by Mallinckrodt Manufacturing of its One-Way Valve, 22F x 22M, as Class I, the most serious.

The recall was issued because the devices are not opening properly, which prevents or reduces the flow of ventilated air or oxygen.

The One-Way Valve, 22F x 22M, is part of the INOmax Delivery System that delivers nitric oxide gas into the tubes between the ventilator and patient airway.

There have been two complaints and no injuries or deaths reported about this issue.

Distribution dates were January 26, 2022, to July 27, 2023.


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