Fresenius Medical Care recalls NaturaLyte Liquid Acid concentrate bottles (Model 08-2301-3) due to sodium and calcium levels below specifications for hemodialysis use. Affected lots include 20LXAC056-057 and others.
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
Fresenius Medical Care is recalling NaturaLyte Liquid Acid concentrate bottles used with hemodialysis machines because the sodium and calcium levels are too low. This could lead to improper treatment and health risks for patients undergoing kidney dialysis.
The concentrates have sodium and calcium levels below what manufacturers specify. This could cause improper dialysis treatment, potentially leading to health issues for patients with kidney failure who rely on these machines.
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 precise dilution requirements.
Check for Model Number 08-2301-3 bottles. Affected lots include 20LXAC056, 20LXAC057, 20NXAC038, 20LXAC041, 20LXAC055, and additional lots listed as of March 17, 2021.
Look for Model Number 08-2301-3 on the bottle label.
Reach out to Fresenius Medical Care for specific instructions on affected lots and next steps.
The sodium and calcium levels are below the manufacturing specifications, which could affect dialysis treatment.
Check for Model Number 08-2301-3 and affected lot numbers listed in the recall notice, including 20LXAC056-057 and others.
The recall does not specify an immediate stop-use requirement; contact Fresenius for specific instructions.
We’ve drafted a message you can send Fresenius to request your refund or repair — edit it as you like.
Subject: Recall Z-0816-2021 — Fresenius Fresenius Hello, I own a Fresenius that is covered by recall Z-0816-2021 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.
