FDA (Devices) recall action 97989
The FDA (Devices) publishes a recall like this one as 6 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 6 pages.
Safety and efficacy of dialysis acid concentrate cannot be assured
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.
Diasol is recalling 186,000 containers of liquid concentrate for bicarbonate dialysis, product 100225-10-DEX100, because the safety and efficacy of the dialysis acid concentrate cannot be assured.
Diasol is recalling 74,400 gallons of liquid concentrate for bicarbonate dialysis, product 100325-10-DEX100, because the safety and efficacy of the dialysis acid concentrate cannot be assured.
Diasol is recalling 4,400 gallons of liquid concentrate for bicarbonate dialysis, product 100230-10-DEX100, because the safety and efficacy of the dialysis acid concentrate cannot be assured.
Diasol is recalling 7,200 gallons of liquid concentrate for bicarbonate dialysis, product 100125-10-DEX100, because the safety and efficacy of the dialysis acid concentrate cannot be assured.
Diasol is recalling 2200 gallons of liquid concentrate for bicarbonate dialysis, product 100425-10-DEX100, because the safety and efficacy of the dialysis acid concentrate cannot be assured.
Diasol is recalling 4400 gallons of liquid concentrate for bicarbonate dialysis, product 100220-10-DEX100, because the safety and efficacy of the dialysis acid concentrate cannot be assured.