Fresenius Medical Care recalls Naturalyte Liquid Acid concentrate drums with product code 13-3251-9 due to sodium level deviations that could affect dialysis treatment safety. Affected lots include 20LXAC023 through 20LXAC089.
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 drums (product code 13-3251-9) because they may have incorrect sodium levels. This could lead to unsafe dialysis treatments if used without proper adjustments.
The concentrate may have sodium levels too high or too low compared to prescriptions. This could cause imbalances in a patient's blood during dialysis treatment.
Patients using Fresenius Renal Technologies dialysis machines with this specific concentrate may be affected. Healthcare providers handling these products are most at risk.
Check for product code 13-3251-9 on the drum. Affected lots include 20LXAC023 through 20LXAC089 as listed in the recall notice.
Look for product code 13-3251-9 on the drum to confirm if it is affected.
The concentrate may have sodium levels that differ from prescriptions, which could affect dialysis treatment safety.
The recall notice does not specify a remedy, so check the product code and contact Fresenius Medical Care for guidance.
Affected lots include 20LXAC023 through 20LXAC089 as listed in the recall notice.
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-0840-2021 — Fresenius Medical Care Fresenius Medical Care Hello, I own a Fresenius Medical Care that is covered by recall Z-0840-2021 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.
