FDA (Devices) recall action 94089
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
When a paraPAC plus ventilator is switched to the operating mode of VENTILATE, the ventilator may intermittently provide continuous positive gas flow instead of the intended cycling like a human breath. This non-cycling and continuous positive gas flow when in the cycling mode, is a malfunction, not allowing the ventilator to properly function as designed.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Smiths Medical is recalling paraPAC plus 310 ventilators that may malfunction by delivering continuous gas flow instead of cycling breaths. The defect affects 10,140 units distributed worldwide and prevents proper ventilation.
Smiths Medical Pneupac Plus 300 ventilators may intermittently deliver continuous airflow instead of cycling breaths as designed. This malfunction affects 2,902 units distributed worldwide.