Fresenius Medical Care recalls Naturalyte Liquid Acid concentrate bottles with specific lot numbers due to sodium concentration exceeding prescriptions and calcium levels below specifications, which could affect hemodialysis 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 is recalling Naturalyte Liquid Acid concentrate bottles (Product Code 08-1251-1) because they contain too much sodium and too little calcium compared to prescriptions. This could lead to incorrect dialysis treatment and health risks for patients using hemodialysis machines.
The bottles have sodium levels higher than prescribed and calcium levels lower than required. This imbalance could cause incorrect dialysis treatment, potentially leading to health issues like electrolyte imbalances.
Patients using hemodialysis machines with Fresenius Renal Technologies Sodium Bicarbonate Concentrate are affected. Those with kidney failure requiring regular dialysis are most at risk.
Check the product code 08-1251-1 on the bottle. Affected lots include 20LXAC063, 20NXAC008, 20NXAC005, 20LXAC098, and 20NXAC039 as of March 17, 2021.
Look for lot numbers 20LXAC063, 20NXAC008, 20NXAC005, 20LXAC098, or 20NXAC039 on the bottle.
The bottles have sodium levels exceeding prescriptions and calcium levels below specifications, which could lead to incorrect dialysis treatment.
Check the lot number on the bottle. If it matches the affected lots listed, contact Fresenius Medical Care for guidance.
The recall record does not specify a remedy or fix for the product.
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-0831-2021 — Fresenius Medical Care Fresenius Medical Care Hello, I own a Fresenius Medical Care that is covered by recall Z-0831-2021 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.
