Fresenius recalls Citrasate Liquid Acid concentrate bottles (Product Code 08-2251-CA) due to sodium level deviations that could affect dialysis treatment safety. Affected lots include 20NXAC007 and others as of March 17, 2021.
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 is recalling Citrasate Liquid Acid concentrate bottles used in hemodialysis machines because they contain sodium levels that may be too high or too low. This could lead to unsafe blood sodium levels during dialysis treatment.
The bottles may have sodium levels that exceed or fall below prescription specifications. This could cause dangerous blood sodium imbalances during dialysis, potentially leading to health complications.
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 for Product Code 08-2251-CA on the bottle. Affected lots include 20NXAC007 and additional lots as of March 17, 2021.
Look for Product Code 08-2251-CA on the bottle label.
The recall does not state that the product is safe to use; it has been recalled due to potential sodium level deviations.
The recall record does not specify a remedy, so no action is required at this time.
Check for Product Code 08-2251-CA and Lot Number 20NXAC007 or additional lots as of March 17, 2021.
We’ve drafted a message you can send Fresenius to request your refund or repair — edit it as you like.
Subject: Recall Z-0834-2021 — Fresenius Fresenius Hello, I own a Fresenius that is covered by recall Z-0834-2021 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.
