Smiths Medical recalls PneuPac ParaPAC Plus 300, 310 ventilators

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Recalled product

• Product Name: Smiths Medical ASD PneuPac paraPAC Plus 300 and 310 Ventilator Kits
• Product Models and Serial Numbers: See Medical Device Recall Database
  • Smiths Medical Pneupac ParaPAC Plus 300 Ventilator Kit With PEEP And CPAP
  • Smiths Medical Pneupac ParaPAC Plus 310 Ventilator Kit With PEEP And CPAP
• Distribution Dates: January 1, 2013 to September 11, 2023
• Devices Recalled in the U.S.: 2,906
• Date Initiated by Firm: February 7, 2024

Device use
Smiths Medical ASD PneuPac paraPAC Plus 300 and 310 Ventilator Kits 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 scene 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.

Reason for recall
Smiths Medical is recalling the PneuPac paraPAC Plus 300 and 310 Ventilator Kits after receiving reports that the ventilator may intermittently provide continuous positive gas flow instead of the intended cycling like a human breath when it is switched to the “Ventilate” operating mode. This non-cycling and continuous positive gas flow when in cycling mode is a malfunction that prevents the ventilator from functioning properly.

As a result of this issue, patients may not receive the right amount of ventilation or enough oxygen (hypoventilation). The issue may also cause a complete or partial airway obstruction. Any of these occurrences can lead to serious injury or death.

Smiths Medical has reported 177 MDR events including 8 reports of serious injury related to this issue. There are currently no reported deaths.

Who may be affected

• People who receive breathing support using the ParaPAC Plus 300 and 310 Ventilator Kits
• Health care providers who provide care for patients using ParaPAC Plus 300 and 310 Ventilator Kits

FDA