FDA (Devices) recall action 91506
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 patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator.
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.
Baxter Healthcare is recalling 8 Life2000 Hospital Ventilator systems due to potential patient desaturation events when the device is connected to an oxygen concentrator.
Baxter Healthcare is recalling 135 Life2000 ventilators nationwide due to potential patient desaturation when connected to an oxygen concentrator.
Baxter Healthcare is recalling 4,279 Life2000 Ventilator Systems due to potential patient desaturation when connected to oxygen concentrators.
The FDA recalls Baxter's Life2000 Ventilator due to potential patient desaturation when connected to an oxygen concentrator. Affects 71 units nationwide.