Fresenius Medical Care recalls Naturalyte Liquid Acid concentrate bottles (Product Code 08-2201-5) 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 is recalling Naturalyte Liquid Acid concentrate bottles used in hemodialysis machines because they may have incorrect sodium levels. This could lead to unsafe dialysis treatments if the bottles are not properly calibrated.
The bottles may have sodium levels that are too high or too low compared to prescription requirements. This deviation could cause unsafe dialysis treatments if the concentration is not properly adjusted.
Patients using hemodialysis machines with Fresenius Renal Technologies Sodium Bicarbonate Concentrate are affected. Those with specific lot numbers are most at risk.
Check for Product Code 08-2201-5 on the bottle. Affected lots include 20LXAC086, 20LXAC099, 20NXAC014, and additional lots listed as of March 17, 2021.
Look for Product Code 08-2201-5 on the bottle label to confirm if it's affected.
The bottles may have sodium levels that exceed or fall below prescribed levels, which could affect dialysis treatment safety.
Affected lots include 20LXAC086, 20LXAC099, 20NXAC014, and additional lots listed as of March 17, 2021.
The recall does not require immediate discontinuation; check the product code and lot number to determine if it's affected.
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-0832-2021 — Fresenius Medical Care Fresenius Medical Care Hello, I own a Fresenius Medical Care that is covered by recall Z-0832-2021 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.
