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Mallinckrodt Manufacturing’s One-Way Valve 22F x 22M is on a one-way trip back to the company after the devices were found to not be opening properly. The US Food and Drug Administration (FDA) tagged the recall of the devices, which are used in gas therapy, as Class I.
Mallinckrodt Manufacturing has recalled 1,799 devices in the US consisting of five valve packs distributed between January 2022 and July 2023.
The valves recalled are used in the INOmax Delivery system, which delivers nitric oxide therapy gas into the tubes between the ventilator and the patient’s breathing circuit. The valve’s function is to prevent the backflow of nitric oxide, without the valve high levels of the gas could reach the patient.
As per an FDA recall alert, the valves have been recalled due to them not opening properly. This can prevent the flow of ventilated air or oxygen. The FDA says that use of the valves could cause serious adverse health consequences. The interruption in ventilation could delay delivery of nitric oxide gas, which could lead to insufficient oxygen in the blood leading to respiratory failure and death. In neonatal and paediatric patients, the delay could additionally lead to bradycardia.
The Class I tag means that continued use of the devices could lead to serious injuries or death. So far, Mallinckrodt Manufacturing has only reported two complaints.
Mallinckrodt Manufacturing told customers of the device to return the valves unless it was in use in a breathing circuit and working as expected.
In August, Mallinckrodt filed for a second bankruptcy in three years in the US.
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- Source: https://www.medicaldevice-network.com/news/fda-tags-mallinckrodts-one-way-valve-recall-as-class-i/