Fresenius recalls NaturaLyte Liquid Acid concentrate bottles (Model 08-4231-0) used in hemodialysis machines due to low sodium/calcium levels. Affected lots: 20LXAC052 and 20LXAC088.
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 contain sodium and calcium levels below the required specifications. This could lead to improper treatment during dialysis.
The bottles have sodium and calcium levels below what manufacturers specify. This could cause improper dialysis treatment if used in hemodialysis machines, potentially leading to treatment errors.
Patients using Fresenius hemodialysis machines with these specific NaturaLyte bottles are affected. Healthcare providers using the product in dialysis treatments are most at risk.
Check for Model Number 08-4231-0 on the bottle. Affected lots include 20LXAC052 and 20LXAC088 (as of March 17, 2021). These bottles are used with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in hemodialysis machines.
Look for Model Number 08-4231-0 on the bottle label.
Reach out to Fresenius Medical Care Holdings, Inc. for assistance with affected lots.
The sodium and calcium levels in these bottles are below the manufacturing specifications, which could lead to improper dialysis treatment.
Affected lots include 20LXAC052 and 20LXAC088 (as of March 17, 2021).
No specific stop-use instruction is provided; the recall focuses on checking model and lot numbers.
We’ve drafted a message you can send Fresenius to request your refund or repair — edit it as you like.
Subject: Recall Z-0822-2021 — Fresenius Fresenius Hello, I own a Fresenius that is covered by recall Z-0822-2021 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.