Fresenius Medical Care recalls Naturalyte Liquid Acid concentrate bottles (Product Code 08-2351-8) due to sodium level deviations that could affect dialysis treatment safety. Affected lots include 20NXAC033 and 20LXAC097.
The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification.
Fresenius Medical Care is recalling Naturalyte Liquid Acid concentrate bottles used in hemodialysis machines because the sodium concentration may be too high or too low. This could lead to unsafe blood levels during dialysis treatment.
The bottles may have sodium levels that exceed or fall below prescribed amounts. This could cause dangerous blood sodium levels during dialysis, potentially leading to health complications.
Patients using hemodialysis machines with Fresenius Renal Technologies Sodium Bicarbonate Concentrate are affected. Those with kidney failure requiring regular dialysis are most at risk.
Check for Product Code 08-2351-8 on the bottle. Affected lots include 20NXAC033 and 20LXAC097. These bottles are used with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in hemodialysis machines.
Look for lot numbers 20NXAC033 or 20LXAC097 on the bottle label.
The sodium concentration in the bottles may be too high or too low, which could affect dialysis treatment safety.
Check the lot number on the bottle. If it's 20NXAC033 or 20LXAC097, contact Fresenius Medical Care for instructions.
The recall is due to potential sodium level deviations that could affect dialysis treatment, but no specific injury risk is stated in the notice.
We’ve drafted a message you can send Fresenius Medical Care to request your refund or repair — edit it as you like.
Subject: Recall Z-0836-2021 — Fresenius Medical Care Fresenius Medical Care Hello, I own a Fresenius Medical Care that is covered by recall Z-0836-2021 from Fresenius Medical Care. 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
