Fresenius recalls Naturalyte Liquid Acid concentrate drums with Product Code 13-2251-0 due to sodium concentration issues that could affect dialysis treatments. Affected lots listed in the recall notice.
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 drums (Product Code 13-2251-0) used in hemodialysis machines. The product may have sodium levels too high or too low, which could cause unsafe dialysis treatments if used without correction.
The product's sodium concentration may be too high or too low compared to prescription levels. This could lead to unsafe dialysis treatments if the product is used without adjustments, potentially causing health issues for patients.
Patients undergoing hemodialysis using this specific product in Fresenius machines are affected. Healthcare providers using the product for dialysis treatments are most at risk.
Check for Product Code 13-2251-0 on the drum. Affected lots include 20LXAC025, 20LXAC081, 20LXAC082, 20LXAC083, and additional lots listed in the recall notice.
Look for Product Code 13-2251-0 on the Naturalyte Liquid Acid concentrate drum.
Reach out to Fresenius Medical Care for specific instructions on handling affected lots.
Product Code 13-2251-0
The product may have sodium levels too high or too low compared to prescription levels, which could affect dialysis treatments.
Check for Product Code 13-2251-0 on the drum. Affected lots include 20LXAC025, 20LXAC081, 20LXAC082, 20LXAC083, and additional lots listed in the recall notice.
We’ve drafted a message you can send Fresenius to request your refund or repair — edit it as you like.
Subject: Recall Z-0839-2021 — Fresenius Fresenius Hello, I own a Fresenius that is covered by recall Z-0839-2021 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.
