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Lower risk Medical device recall · FDA · Published September 29, 2017

Fresenius NaturaLyte Liquid Acid Concentrate 2.0 mEq/L Potassium Too High Risk

Fresenius Medical Care recalls NaturaLyte Liquid Acid Concentrate 2.0 mEq/L (Model 08-2251-0) due to potassium concentration exceeding 2.0 mEq/L in some batches, which may cause health risks during hemodialysis.

🇺🇸 FDA recall #Z-1010-2018Medical deviceFresenius Medical Care ›
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Recalling firmFresenius Medical Care Renal Therapies Group, LLC920 Winter St · Waltham, MA 02451-1521
✎ GovInfoNow plain-language explainer

What happened, in plain English

Fresenius Medical Care is recalling NaturaLyte Liquid Acid Concentrate 2.0 mEq/L (Model 08-2251-0) because some bottles had potassium levels of 2.25 mEq/L instead of the labeled 2.0 mEq/L. This could lead to health issues during hemodialysis treatments. Read more at govinfonow.com/recall/72930-fresenius-naturalyte-liquid-acid-concentrate-2-0-meq-l-potassium.

Source Summary by GovInfoNow · govinfonow.com/recall/72930-fresenius-naturalyte-liquid-acid-concentrate-2-0-meq-l-potassium · Updated September 17, 2026 · FDA enforcement record: FDA #Z-1010-2018

Cite this page

“Fresenius NaturaLyte Liquid Acid Concentrate 2.0 mEq/L Potassium Too High Risk.” GovInfoNow, updated September 17, 2026. https://govinfonow.com/recall/72930-fresenius-naturalyte-liquid-acid-concentrate-2-0-meq-l-potassium. Based on FDA recall #Z-1010-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1010-2018%22&limit=1).

Why it’s dangerous

The product is designed for use with hemodialysis machines. Higher potassium levels than labeled (2.25 mEq/L instead of 2.0 mEq/L) could cause health issues during treatment if not properly managed.

Who’s affected

Patients using hemodialysis machines with this product are most at risk. The affected product is used in specific medical treatments for kidney failure.

How to tell if you have this one

Check for the model number 08-2251-0 on the bottle. The affected lot number is 17KTAC076. This product is sold in 3.43-liter bottles.

  • Brand
    Fresenius Medical Care
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Label

    Look for the model number 08-2251-0 and lot number 17KTAC076 on the bottle.

Where it went and when

Where it was distributed

Distributed in 5 states.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: yesCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: yesKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: yesLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: yesTXFlorida: yesFL

FDA distribution: “US Distribution to states of: CA, FL, KS, LA, and TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: California, Florida, Kansas, Louisiana, Texas.

Recall timeline

FDA terminated this recall 10 months after the firm started it.

1. Firm started the recall: Sep 29, 201712. FDA classified it Class II: Mar 14, 201823. Published in FDA’s Enforcement Report: Mar 21, 201834. FDA terminated the recall: Aug 9, 2018420172018
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

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-1010-2018 (September 29, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1010-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on September 17, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA