Fresenius recalls NaturaLyte Liquid Acid concentrate bottles (Model 08-1301-4) used in hemodialysis machines due to low sodium/calcium levels. Affected units may cause improper treatment.
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
Fresenius is recalling NaturaLyte Liquid Acid concentrate bottles (Model 08-1301-4) used with hemodialysis machines because they may have sodium and calcium levels below what's needed. This could lead to improper dialysis treatment if used without correction.
The concentrate bottles may have sodium and calcium levels below the required manufacturing standards. This could cause improper dialysis treatment if the bottles are used without adjustment, potentially leading to health issues.
Patients using hemodialysis machines with Fresenius Renal Technologies Sodium Bicarbonate Concentrate are affected. Those with the specific bottle model number 08-1301-4 are most at risk.
Check for the model number 08-1301-4 on the bottle. These bottles are used with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in hemodialysis machines. Lot number 20LXAC042 is also associated with this recall.
Look for the model number 08-1301-4 on the bottle label.
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications, which could lead to improper dialysis treatment.
Check for the model number 08-1301-4 on the bottle, which is used with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in hemodialysis machines.
The recall record does not specify a remedy, so contact Fresenius Medical Care Holdings, Inc. for guidance.
We’ve drafted a message you can send Fresenius to request your refund or repair — edit it as you like.
Subject: Recall Z-0812-2021 — Fresenius Fresenius Hello, I own a Fresenius that is covered by recall Z-0812-2021 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.
