Fresenius recalls Naturalyte Liquid Acid concentrate bottles with product code 08-3251-9 due to sodium level deviations that could affect dialysis treatment safety.
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 recalls Naturalyte Liquid Acid concentrate bottles (product code 08-3251-9) because they contain sodium levels outside the prescribed range. This could lead to incorrect dialysis treatment if used in hemodialysis machines.
The bottles have sodium levels that are too high or too low compared to medical prescriptions. This deviation could cause incorrect dialysis treatment if the bottles are used in hemodialysis machines without adjustment.
Patients using hemodialysis machines with Fresenius Renal Technologies Sodium Bicarbonate Concentrate are affected. Those with kidney failure requiring dialysis are most at risk.
Check for product code 08-3251-9 on the bottles. The affected lots include 20LXAC058, 20LXAC078, 20LXAC096, 20NXAC011, 20NXAC012, and additional lots listed in the recall notice.
Look for product code 08-3251-9 on the bottles.
The product code is 08-3251-9.
Affected lots include 20LXAC058, 20LXAC078, 20LXAC096, 20NXAC011, 20NXAC012, and additional lots listed in the recall notice as of March 17, 2021.
The bottles have sodium levels that exceed or fall below the prescribed range, which could affect dialysis treatment safety.
We’ve drafted a message you can send Fresenius to request your refund or repair — edit it as you like.
Subject: Recall Z-0837-2021 — Fresenius Fresenius Hello, I own a Fresenius that is covered by recall Z-0837-2021 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.
