Fresenius recalls NaturaLyte Liquid Acid concentrate bottles (Model 08-3251-9) used in hemodialysis machines due to low sodium/calcium levels. Affected lots include 20LXAC043-096. Contact Fresenius for details.
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
Fresenius is recalling NaturaLyte Liquid Acid concentrate bottles used in hemodialysis machines because they may have sodium and calcium levels below what's needed. This could lead to improper treatment if used without correction.
These bottles are used in hemodialysis machines to treat kidney failure. If sodium or calcium levels are too low, the treatment might not work properly, potentially causing health issues for patients.
Patients using hemodialysis machines with Fresenius Renal Technologies Sodium Bicarbonate Concentrate are most at risk. The affected bottles are used in specific medical settings with limited general availability.
Check for Model Number 08-3251-9 on the bottle. The affected lots include 20LXAC043 through 20LXAC096 and additional lots added as of March 17, 2021.
Look for Model Number 08-3251-9 on the bottle label.
Reach out to Fresenius Medical Care for specific guidance on affected lots and next steps.
The sodium and calcium levels in these concentrates were below manufacturing specifications, which could affect hemodialysis treatment effectiveness.
Check the model number and lot numbers listed in the recall notice. Contact Fresenius Medical Care for specific instructions.
While the product is used in medical settings, low sodium/calcium levels could lead to improper treatment. However, the recall is for correction, not immediate danger.
We’ve drafted a message you can send Fresenius to request your refund or repair — edit it as you like.
Subject: Recall Z-0820-2021 — Fresenius Fresenius Hello, I own a Fresenius that is covered by recall Z-0820-2021 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.