Fresenius recalls NaturaLyte Liquid Acid concentrate bottles (Model 08-2201-5) due to low sodium and calcium levels, which may affect hemodialysis treatments. Affected lots include 20LXAC061, 20NXAC036, and others.
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
Fresenius recalls NaturaLyte Liquid Acid concentrate bottles (Model 08-2201-5) because they may have sodium and calcium levels below the required specifications. This could lead to improper dialysis treatment outcomes if used in hemodialysis machines.
The concentrates may have sodium and calcium levels below the required specifications when used in hemodialysis machines. This could lead to improper treatment outcomes, but the hazard is not described as causing immediate injury.
Patients using hemodialysis machines with Fresenius Renal Technologies Sodium Bicarbonate Concentrate are affected. Those with the specific model numbers and lot numbers listed are most at risk.
Check for Model Number 08-2201-5 bottles used with Fresenius Renal Technologies Sodium Bicarbonate Concentrate. Affected lots include 20LXAC061, 20NXAC036, 20LXAC062, 20LXAC099, 20LXAC086, and 20NXAC014.
Compare your lot numbers to the list: 20LXAC061, 20NXAC036, 20LXAC062, 20LXAC099, 20LXAC086, 20NXAC014.
The sodium and calcium levels in these concentrates were below the manufacturing specifications, which could affect hemodialysis treatment outcomes.
Check your lot numbers against the list provided. If affected, contact Fresenius for guidance.
The recall record does not specify a remedy or fix.
We’ve drafted a message you can send Fresenius to request your refund or repair — edit it as you like.
Subject: Recall Z-0813-2021 — Fresenius Fresenius Hello, I own a Fresenius that is covered by recall Z-0813-2021 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.
