Fresenius Medical Care recalls NaturaLyte Liquid Acid concentrate bottles (Model 08-3201-4) due to sodium and calcium levels below specifications for hemodialysis use. Affected lots: 20LXAC038, 20NXAC032.
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
Fresenius Medical Care is recalling NaturaLyte Liquid Acid concentrate bottles (Model 08-3201-4) because they may have sodium and calcium levels below the required specifications for use in hemodialysis machines. This could lead to improper treatment if used without correction.
The concentrates may have sodium and calcium levels below what's needed for proper hemodialysis treatment. This could cause treatment inefficiency or incorrect dosing if not corrected, but does not pose an immediate safety risk like injury or death.
Patients using hemodialysis machines with Fresenius Renal Technologies Sodium Bicarbonate Concentrate may be affected. Those with the specific lot numbers 20LXAC038 and 20NXAC032 are most at risk.
Check for the model number 08-3201-4 on the bottle. The lot numbers 20LXAC038 and 20NXAC032 are affected. These bottles are used with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in hemodialysis machines.
Look for lot numbers 20LXAC038 or 20NXAC032 on the bottle label.
The sodium and calcium levels in these concentrates were below the manufacturing specifications for hemodialysis use.
Check the lot number on the bottle. If it's 20LXAC038 or 20NXAC032, contact Fresenius Medical Care for guidance.
The recall is for potential treatment inefficiency, not an immediate safety risk like injury or death.
We’ve drafted a message you can send Fresenius Medical Care to request your refund or repair — edit it as you like.
Subject: Recall Z-0818-2021 — Fresenius Medical Care Fresenius Medical Care Hello, I own a Fresenius Medical Care that is covered by recall Z-0818-2021 from Fresenius Medical Care. 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.
