Fresenius Medical Care recalls NaturaLyte Liquid Acid Concentrate for Bicarbonate Dialysis due to mislabeled part numbers. This affects 3.43L bottles with part number 08-3231-1. No action is required as the product is safe but must be correctly labeled.
The bottles are mislabeled with an incorrect part number.
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Contact the company
📍Recalling firmFresenius Medical Care Renal Therapies Group, LLC920 Winter St · Waltham, MA 02451-1521
✎ GovInfoNow plain-language explainer
Fresenius Medical Care is recalling NaturaLyte Liquid Acid Concentrate for Bicarbonate Dialysis because the bottles have incorrect part numbers. This mislabeling could lead to improper use in dialysis machines, but the product itself is safe and no action is needed. Read more at govinfonow.com/recall/71214-fresenius-naturalyte-liquid-acid-concentrate-mislabeling-recall.
“Fresenius NaturaLyte Liquid Acid Concentrate Mislabeling Recall.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/71214-fresenius-naturalyte-liquid-acid-concentrate-mislabeling-recall. Based on FDA recall #Z-2110-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2110-2018%22&limit=1).
The FDA announced on May 2, 2018, that Fresenius Medical Care Renal Therapies Group LLC recalled NaturaLyte Liquid Acid Concentrate for Bicarbonate Dialysis due to mislabeled bottles with incorrect part numbers. The agency classified the recall as Class II.
How to tell if you have it
Brand: Fresenius
Product: NaturaLyte Liquid Acid Concentrate for Bicarbonate Dialysis, 3.43 Liters
Part Number: 08-3231-1
Lot Code: 18CXAC095
The hazard
The bottles are mislabeled with an incorrect part number, according to the FDA.
Context
GovInfoNow's records show Fresenius Medical Care Renal Therapies Group LLC has 15 other recalls on record since September 29, 2017. Other recent recalls of similar products include Fresenius Medical Care Bicarby Dialysate Recall (May 7, 2026), Fresenius 5008X Blood Tubing Set Recall (May 11, 2026), and MedicaLyte Bicarbonate Powder Recall (August 5, 2026).
How to tell if you have this one
Check for the part number 08-3231-1 on the bottle label. The product is a 3.43-liter liquid acid concentrate for bicarbonate dialysis used in hemodialysis machines.
Brand
Fresen:ius
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Verify Part Number
Check the bottle label for part number 08-3231-1. If it matches, the product is correctly labeled and no action is needed.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 17 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide Distribution - US Nationwide in the states: CA, IA, IL, IN, KS, MD, MI, MN, MS, NE, NJ, NV, OK, PA, SD, TX, and WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Illinois, Indiana, Iowa, Kansas, Maryland, Michigan, Minnesota, Mississippi, Nebraska, Nevada, New Jersey, Oklahoma, Pennsylvania, South Dakota, Texas, Wisconsin.
Recall timeline
FDA terminated this recall 2 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-2110-2018 (May 2, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2110-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.