FDA (Devices) recall action 84588
The FDA (Devices) publishes a recall like this one as 4 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 4 pages.
There is the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is created between the water bottle and the column during high flow oxygen therapy.
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.
Teleflex Medical is recalling 30,566 Hudson RCI Comfort Flo humidifier nebulizer kits because water may flood the column and enter the circuit during high-flow oxygen therapy.
Teleflex Medical is recalling 60,467 Hudson RCI Comfort Flo Corrugated Humidification Systems because water may flood the column and enter the circuit during high-flow oxygen therapy.
Teleflex Medical is recalling 127,293 Hudson RCI Comfort Flo Humidification Systems nationwide due to a potential risk of water flooding the column and entering the circuit during high-flow oxygen therapy.
Teleflex Medical is recalling 95,696 Hudson RCI Comfort Flo Humidification Systems due to a potential risk of water flooding the column and entering the patient circuit during high-flow oxygen therapy.