Fresenius recalls Citrasate Liquid Acid concentrate drums (Model 13-2251-CA) for potential low sodium/calcium levels in dialysis machines. Affected lots include 20LXAC031 and others listed. No remedy specified in recall notice.
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
Fresenius Medical Care recalls Citrasate Liquid Acid concentrate drums used in hemodialysis machines because the sodium and calcium levels may be too low. This could affect dialysis treatment safety if the machine uses the concentrate improperly.
The concentrate may have sodium and calcium levels below what's needed for proper dialysis. This could lead to imbalances in the patient's blood, but the risk is not immediate or severe under normal use conditions.
Patients using hemodialysis machines with Fresenius Renal Technologies Sodium Bicarbonate Concentrate are affected. Those with specific lot numbers listed in the recall are most at risk.
Check for Model Number 13-2251-CA on the drum. Affected lots include 20LXAC031, 20NXAC004, 20LXAC033, 20NXAC003, and 20LXAC032. The product is used with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in hemodialysis machines.
Look for lot numbers 20LXAC031, 20NXAC004, 20LXAC033, 20NXAC003, or 20LXAC032 on the drum.
The recall states the sodium and calcium levels may be too low, but no specific remedy is provided. Users should check the lot number and contact Fresenius if concerned.
The recall does not specify a remedy. Check the lot number and contact Fresenius Medical Care if you have the affected model and lot numbers listed.
The low sodium/calcium levels could cause blood imbalances during dialysis, but the recall does not indicate immediate danger or a need to stop use.
We’ve drafted a message you can send Fresenius to request your refund or repair — edit it as you like.
Subject: Recall Z-0828-2021 — Fresenius Fresenius Hello, I own a Fresenius that is covered by recall Z-0828-2021 from Fresenius. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
