INDIANA—Smiths Medical is recalling paraPAC plus P300 and P310 ventilators because the patient outlet connector may loosen or detach, impacting 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.
The U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall. This recall involves removing certain devices from where they are used or sold. If you continue to use this device, it may cause serious injury or death.