FDA (Devices) recall action 67313
The FDA (Devices) publishes a recall like this one as 9 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 9 pages.
Dialysate Port Leak During Priming of the Dialyzers
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.
Fresenius Medical Care is recalling Optiflux F160NRe dialyzers because the dialysate port may leak during priming. The recall covers 3.4 million units distributed in the US and Mexico.
Fresenius Medical Care is recalling 5,244 Optiflux F200A dialyzers due to a dialysate port leak during priming.
Fresenius Medical Care is recalling Optiflux F180NRe dialyzers because the dialysate port may leak during priming, potentially compromising treatment.
Fresenius Medical Care is recalling Optiflux F180NR dialyzers due to a dialysate port leak during priming. The recall covers 52,752 units distributed in the US and Mexico.
Fresenius Medical Care is recalling Optiflux F200NRe dialyzers because the dialysate port may leak during priming, posing a risk to patients.
Fresenius Medical Care is recalling Optiflux F160NR dialyzers because the dialysate port may leak during priming. The recall covers 6,720 units distributed in the US and Mexico.
Fresenius Medical Care is recalling 34,752 Optiflux F18Nre Flux Dialyzers because the dialysate port may leak during priming.
Fresenius Medical Care is recalling 100,008 Optiflux B200 Flux Dialyzers because the dialysate port may leak during priming.
Fresenius Medical Care is recalling 19,596 Optiflux F200NR dialyzers due to a dialysate port leak during priming. The units were distributed in the US and Mexico.