Fresenius Medical Care recalls NaturaLyte Liquid Acid concentrate (part number 08-0231-4) due to incorrect potassium chloride labeling on labels. This affects dialysis patients using the product.
The "Nominal Chemical Composition" section of the label incorrectly lists 5.62g/L KCL (potassium chloride). 5.62g/L actually corresponds to the CaCl (calcium chloride) content. The product remains potassium free.
Fresenius Medical Care is recalling NaturaLyte Liquid Acid concentrate for dialysis because the label incorrectly lists potassium chloride (KCL) when it should be calcium chloride. This could cause confusion for patients using the product.
The label incorrectly states 5.62g/L of potassium chloride (KCL) when it actually contains calcium chloride. The product remains potassium free, so it does not contain potassium. This labeling error could cause confusion for patients using the product.
Dialysis patients using NaturaLyte Liquid Acid concentrate (part number 08-0231-4) are affected. Patients using the product with the listed lot numbers are most at risk.
Check for the product name 'NaturaLyte Liquid Acid concentrate', part number 08-0231-4, and lot numbers listed: 20LTAC076, 20PTAC094, 21ATAC046, 21BTAC082, 21CTAC029, 21KTAC072, 21PTAC023, 21STAC094, 22DTAC036.
Look for the part number 08-0231-4 and lot numbers listed in the recall notice.
Yes, the product remains potassium free and is safe for dialysis use, but the labeling error may cause confusion.
The recall notice does not specify a remedy, so check with your healthcare provider for guidance.
Affected lot numbers are: 20LTAC076, 20PTAC094, 21ATAC046, 21BTAC082, 21CTAC029, 21KTAC072, 21PTAC023, 21STAC094, 22DTAC036.
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-0181-2023 — Fresenius Medical Care Fresenius Medical Care Hello, I own a Fresenius Medical Care that is covered by recall Z-0181-2023 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.
