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
- 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
What to Do
On February 7, 2024, Smiths Medical sent an Urgent Medical Device Correction notice to customers with the following information:
Recommendations for health care providers
- There is no need to return or discontinue using paraPAC Plus at this time.
- When using the device, all instructions, including warnings and cautions in the User Manual Document (numbers 10018833-003 and/or 10026347-002) must be followed with heightened awareness, including but not limited to:
- Constant monitoring of the patient
- Blood oxygenation and expired carbon dioxide levels should be monitored independently using pulse oximetry and capnography
- All pre-use checks must be performed before each use
- Alternative means of ventilation such as bag mask ventilation, must be available in the event of ventilator failure or malfunction
- If the paraPac plus ventilator experiences continuous flow, remove the ventilator from clinical use, set the device aside for repair and use another device or alternative means of ventilation
Required actions for customers
- Identify all paraPAC plus units in your possession.
- Share this recall notification with all potential users of the devices, including if the devices are used at another location.
- Complete and return the attached Customer Response Form to [email protected].
- For distributors: If potentially affected products were distributed, immediately forward this notice. Request that they complete the response form and return it to [email protected].
Contact Information
Customers with questions should contact their sales representative or call 763-383-3072.
