Fresenius Medical Care recalls Naturalyte Liquid Acid concentrate bottles (Product Code 08-2301-3) due to sodium level deviations that could affect dialysis treatment safety. Affected lots include 20NXAC013, 20NXAC035, and others listed. Contact for remedy details.
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 that may have incorrect sodium levels, which could lead to unsafe dialysis treatments. This affects patients using these bottles with Fresenius Renal Technologies equipment. The recall is for specific lot numbers.
The bottles may have sodium levels higher than prescribed, which could cause imbalances during dialysis. Calcium levels are also below the required standard, potentially affecting treatment effectiveness.
Patients using Fresenius Naturalyte Liquid Acid concentrate bottles in dialysis treatments are affected. Those with specific lot numbers listed in the recall are most at risk.
Check the product code 08-2301-3 on the bottle. Affected lots include 20NXAC013, 20NXAC035, and additional lots listed as of March 17, 2021.
Look for lot numbers 20NXAC013, 20NXAC035, or other affected lots listed in the recall.
The product code is 08-2301-3.
Affected lot numbers include 20NXAC013, 20NXAC035, and additional lots listed as of March 17, 2021.
The bottles may have sodium levels higher than prescribed, which could affect dialysis safety, and calcium levels are below the required standard.
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-0835-2021 — Fresenius Medical Care Fresenius Medical Care Hello, I own a Fresenius Medical Care that is covered by recall Z-0835-2021 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.
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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.
