Fresenius Medical Care recalls Naturalyte Liquid Acid concentrate bottles with Product Code 08-2251-0 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. The bottles may have incorrect sodium levels, which could lead to unsafe dialysis treatments if used as intended.
The bottles may have sodium levels higher or lower than prescribed, which could cause imbalances in dialysis treatment. Calcium concentration is also below the required level, potentially affecting treatment effectiveness.
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 Product Code 08-2251-0 on the bottle. Affected lots include 20LXAC076, 20LXAC077, 20LXAC091, 20LXAC101, and 20NXAC010, with additional lots added through March 17, 2021.
Look for Product Code 08-2251-0 on the bottle label.
The bottles may have incorrect sodium levels and lower calcium concentration than specified, which could affect dialysis treatment safety.
The official recall notice does not specify a remedy or action for affected products.
Affected lots include 20LXAC076, 20LXAC077, 20LXAC091, 20LXAC101, 20NXAC010, and additional lots added through March 17, 2021.
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-0833-2021 — Fresenius Medical Care Fresenius Medical Care Hello, I own a Fresenius Medical Care that is covered by recall Z-0833-2021 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.
