Fresenius recalls Naturalyte Liquid Acid concentrate bottles with Product Code 08-4231-0 due to sodium level exceeding prescriptions by 6mEq/L, potentially causing unsafe dialysis treatments.
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 sodium levels too high for safe dialysis use. This could lead to unsafe blood sodium levels during hemodialysis treatments if used without correction.
The bottles may contain sodium levels higher than prescribed, which could cause dangerous blood sodium imbalances during dialysis. Calcium levels are also below the required specification, potentially affecting treatment effectiveness.
Patients using Fresenius Renal Technologies dialysis machines with Naturalyte Liquid Acid concentrate bottles are affected. Those with kidney failure requiring hemodialysis are at highest risk.
Check for Product Code 08-4231-0 on the bottle. Affected lots include 20LXAC088 and 20LXAC052 as of March 17, 2021. These bottles are used with Fresenius Renal Technologies dialysis machines.
Look for lot numbers 20LXAC088 or 20LXAC052 on the bottle label.
Reach out to Fresenius Medical Care for specific instructions on safe use or replacement.
The bottles may have sodium levels exceeding prescribed amounts by 6mEq/L, which could cause unsafe blood sodium levels during dialysis treatments.
Check the lot number on the bottle. If it's 20LXAC088 or 20LXAC052, contact Fresenius Medical Care for guidance on safe use or replacement.
The recall is due to potential sodium imbalances during dialysis, but the official notice does not specify a risk of serious injury in normal use.
We’ve drafted a message you can send Fresenius to request your refund or repair — edit it as you like.
Subject: Recall Z-0838-2021 — Fresenius Fresenius Hello, I own a Fresenius that is covered by recall Z-0838-2021 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.
