Smiths Recalls ParaPAC Ventilators

Smiths Medical is recalling (Class 1) its ParaPAC plus P300 and P310 ventilators due to the possibility that patient outlet connectors may become loose or detach altogether, which will impact active ventilation. “If the patient outlet connector is loosened or detached it could cause extended interruption of therapy, no ventilation, delay of therapy and reduced tidal volume,” a recall notice says.

Using an affected product may cause serious adverse health consequences, including hypoventilation, hypoxia, bradycardia, hypotension, respiratory arrest, and death, the notice says. To date, there has been one reported injury and one reported death.

The gas-powered emergency and transport portable ventilators are used for emergency use at accident scenes and during transports between hospitals or within a hospital or medical facility. They also provide free-flow oxygen therapy and continuous positive airway pressure therapy for spontaneously breathing patients.