FDA (Devices) recall action 63174
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.
Accutron is recalling the Flowmeter (Analgesia Gas Machine) because when it flows Nitrous Gas without Oxygen gas being turned on, it functions in an incorrect manner.
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.
Accutron is recalling 220 Flowmeter packages used in analgesia gas machines because they may function incorrectly when nitrous gas flows without oxygen.
Accutron is recalling specific Flowmeter assemblies used in analgesia gas machines because they function incorrectly when nitrous gas flows without oxygen.
Accutron is recalling 220 Newport Portable Analgesia Gas Machines because the flowmeter functions incorrectly when nitrous gas flows without oxygen.
Accutron is recalling 220 Ultra PC Cabinet Mount Packages because the flowmeter may function incorrectly when nitrous gas flows without oxygen.