Ventilator Recall: Smiths Medical Removes ParaPAC Plus Ventilators due to Loosened or Detached Patient Outlet Connector | FDA

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.

On May 31, 2024, Smiths Medical sent all affected customers an Urgent Medical Device Correction letter recommending the following actions:

Smiths Medical is recalling paraPAC plus P300 and P310 ventilators due to the possibility that the patient outlet connector may loosen or detach, 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.

The use of affected product may cause serious adverse health consequences, including not enough ventilation (hypoventilation), not enough oxygen (hypoxia), slowed heart beat (bradycardia), low blood pressure (hypotension), a sudden stop of the lungs (respiratory arrest), and death.

There has been one reported injury. There has been one report of death.

Smiths Medical PneuPAC paraPAC Plus P300 and P310 Ventilators are gas-powered emergency and transport portable ventilators, including in vehicles such as airplanes and helicopters. They are suitable for emergency use at an accident scenes and transports between hospitals or within a hospital or medical facility. These ventilators are intended to provide ventilatory support for adults, children, and infants (above approx. 10 kg).

The paraPAC Plus devices also provide free flow oxygen therapy and continuous positive airway pressure (CPAP) therapy for spontaneously breathing patients. The devices can also be used in emergency situations to provide ventilatory support for CPR resuscitation.

ParaPAC Plus ventilators should only be used under the constant supervision of trained health care professionals.

Customers in the U.S. with questions about this recall should contact Smiths Medical Technical Support at 1-800-241-4002, option 3.

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

09/20/2024