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Lower risk Medical device recall · FDA · Published December 17, 2020

Fresenius Medical Care NaturaLyte Liquid Acid Concentrate Recall: Missing Product Label

Fresenius Medical Care recalls NaturaLyte Liquid Acid concentrate for bicarbonate hemodialysis due to missing product labels. Affected units have part number 08-3251-9 and lot code 20NTAC040.

🇺🇸 FDA recall #Z-0942-2021Medical deviceFresenius Medical Care ›
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Recalling firmFresenius Medical Care Holdings, Inc.920 Winter St Bld 950 · Waltham, MA 02451-1521
✎ GovInfoNow plain-language explainer

What happened, in plain English

Fresenius Medical Care is recalling NaturaLyte Liquid Acid concentrate for bicarbonate hemodialysis because bottles may be missing product labels. This could lead to incorrect dosing if the label is not visible. Read more at govinfonow.com/recall/63644-fresenius-medical-care-naturalyte-liquid-acid-concentrate-recall-missing-product.

Source Summary by GovInfoNow · govinfonow.com/recall/63644-fresenius-medical-care-naturalyte-liquid-acid-concentrate-recall-missing-product · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0942-2021

Cite this page

“Fresenius Medical Care NaturaLyte Liquid Acid Concentrate Recall: Missing Product Label.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63644-fresenius-medical-care-naturalyte-liquid-acid-concentrate-recall-missing-product. Based on FDA recall #Z-0942-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0942-2021%22&limit=1).

Why it’s dangerous

Missing product labels could cause incorrect dosing during hemodialysis. This might lead to improper treatment or health complications if the concentration is not accurately known.

Who’s affected

Healthcare providers using this product for hemodialysis. Patients on dialysis who receive this concentrate are at risk if the label is missing.

How to tell if you have this one

Check for part number 08-3251-9 and lot code 20NTAC040 on the bottle. The product is used for bicarbonate hemodialysis.

  • 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 product label on the bottle to confirm it is not missing.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 2.1 years after the firm started it.

1. Firm started the recall: Dec 17, 202012. FDA classified it Class II: Feb 1, 202123. Published in FDA’s Enforcement Report: Feb 10, 202134. FDA terminated the recall: Jan 5, 2023420202023
  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-0942-2021 (December 17, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0942-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 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