The FDA is elevating three sets of respiratory hardware recalls from Smiths Medical, covering portable ventilators and tracheostomy tubes that enter the airway through the neck. The agency categorized each of them as Class I recalls, its most serious type.
ICU Medical’s Smiths Medical division first began notifying healthcare providers of the separate issues in late May and early June and advised customers to stop using any of the affected devices.
They include all models of the company’s Pneupac ParaPAC P300 and P310 ventilator kits, with about 27,000 total systems distributed worldwide, according to the FDA. The gas-powered ventilators are used in patient transports—such as during helicopter flights as well as between units within a hospital—and can also deliver support at the scene of an accident, including assistance in CPR.
The FDA said it has received reports of one injury and one death linked to the possibility of the patient hose connector loosening or detaching during use, interrupting the flow of air. In its Sept. 20 letter seeking to get the word out to providers, the agency said to remove any ParaPAC ventilator from use if the outlet connector moves when inspected so that it can be repaired by Smiths Medical.
The company also issued an urgent medical device correction for the same equipment earlier this year, notifying users that the tidal volume setting knob may move, potentially over- or under-delivering ventilation to the patient.
Meanwhile, Smiths Medical’s Bivona Aire-Cuf neonatal, pediatric and adult tracheostomy tubes were recalled due to a manufacturing defect among specific lots, which may cause the securing flanges to tear off the sides of the tube. The FDA said Sept. 18 that it is aware of 35 reported injuries and two deaths.
Separately, the agency issued Class I recall labels Sept. 11 to the company’s BLUperc, BLUgriggs and BLUselect tracheostomy kits—spanning about 850,000 units worldwide—over a manufacturing defect that could cause the pilot balloon to disconnect from the inflation line. The FDA has not listed any patient injuries in its recall notices.
This past March, the FDA amplified a Class I recall covering more than 85,000 of Smiths Medical’s Medfusion syringe pumps, distributed in the U.S. across a period of more than 20 years, linked to software in need of updating.