Mallinckrodt Recalls One-Way Ventilator Valve

Mallinckrodt has recalled its One-Way Valve, 22F x 22M due to reports about the devices not opening properly, which prevents or reduces the flow of ventilated air or oxygen. The device is part of the INOmax Delivery System, which delivers nitric oxide therapy gas into the tubes between the ventilator and patient airway (breathing circuit), according to a recall notice, adding that the valve is used to prevent backward flow of nitric oxide gas into the INOmax injector module. To date there have been two complaints and no reports of injuries.

The use of the One-Way Valve may cause serious adverse health consequences, including ventilation interruption, which may delay delivery of nitric oxide gas, the notice says. “This delay could lead to bradycardia in neonatal or pediatric patients,” it says, adding that any interruption may lead to insufficient oxygen in the blood that could cause respiratory failure, and death.