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Lower risk Medical device recall · FDA · Published November 7, 2020

Fresenius NaturaLyte Liquid Acid Concentrate Drums Recall: Low Sodium/Calcium Levels

Fresenius recalls NaturaLyte Liquid Acid concentrate drums (Model 13-1251-1) used in hemodialysis machines due to low sodium/calcium levels. Check lot numbers 20LXAC034, 20LXAC069, 20NXAC040 for affected units.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0823-2021Medical deviceFresenius ›
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Recalling firmFresenius Medical Care Holdings, Inc.920 Winter St Bld 950 · Waltham, MA 02451-1521
✎ GovInfoNow plain-language explainer

Fresenius Medical Care recalls NaturaLyte Liquid Acid concentrate drums (Model 13-1251-1) used in hemodialysis machines because sodium and calcium levels were below specifications. This could affect dialysis treatment safety if the concentrate isn't properly diluted. Read more at govinfonow.com/recall/63958-fresenius-naturalyte-liquid-acid-concentrate-drums-recall-low-sodium-calcium.

Source Summary by GovInfoNow · govinfonow.com/recall/63958-fresenius-naturalyte-liquid-acid-concentrate-drums-recall-low-sodium-calcium · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0823-2021

Cite this page

“Fresenius NaturaLyte Liquid Acid Concentrate Drums Recall: Low Sodium/Calcium Levels.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63958-fresenius-naturalyte-liquid-acid-concentrate-drums-recall-low-sodium-calcium. Based on FDA recall #Z-0823-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0823-2021%22&limit=1).

Fresenius Medical Care Holdings, Inc. recalled NaturaLyte Liquid Acid concentrate drums due to sodium and/or calcium levels below manufacturing specifications, according to the FDA on November 7, 2020.

How to tell if you have it

  • Brand: Fresenius
  • Product: NaturaLyte Liquid Acid concentrate drums
  • Model Number: 13-1251-1
  • Lot Numbers: 20LXAC034, 20LXAC069, 20NXAC040
  • Quantity: 51 drums

The hazard

The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.

Context

GovInfoNow's records show Fresenius Medical Care Holdings, Inc. has 44 other recalls on record since April 14, 2014. Other recent recalls of similar products include Fresenius NaturaLyte Liquid Acid Concentrate Recall (July 14, 2026), Fresenius Medical Care Citrasate Liquid Acid Concentrate Recall (July 14, 2026), and Fresenius Medical Care GRANUFLO Dry Acid Concentrate Recall (July 14, 2026).

How to tell if you have this one

Check if you have NaturaLyte Liquid Acid concentrate drums with Model Number 13-1251-1. Look for lot numbers 20LXAC034, 20LXAC069, or 20NXAC040 on the drums.

  • Brand
    Fresenius
  • Category
    Medical device
FDA recall event · 19 products

All 19 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    US Nationwide distribution.
Recall numberProduct, codes & lotsQuantity
Z-0811-2021NaturaLyte Liquid Acid concentrate bottles, Model Number 08-1251-1 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.; Lot Numbers: 20NXAC005 20LXAC098 20NXAC037 20NXAC039 Additional affected lots as of 3/17/21: 20NXAC008 20LXAC0633665 cases
Z-0812-2021NaturaLyte Liquid Acid concentrate bottles, Model Number 08-1301-4 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.; Lot Numbers: 20LXAC042527 cases
Z-0813-2021NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2201-5 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.; Lot Numbers: 20LXAC061 20NXAC036 20LXAC062 Additional affected lots as of 3/17/21: 20LXAC099 20LXAC086 20NXAC0145765 cases
Z-0814-2021NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2231-2 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.; Lot Numbers: 20NXAC034180 cases
Z-0815-2021NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.; Lot Numbers: 20LXAC048 20LXAC053 20LXAC047 20NXAC016 20LXAC094 20NXAC009 20LXAC049 20LXAC054 20NXAC025 20NXAC024 Additional Affected lots as of 3/17/21: 20LXAC076 20LXAC077 20LXAC091 20LXAC101 20NXAC010 20NXAC01611709 cases
Z-0816-2021NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2301-3 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.; Lot Numbers: 20LXAC056 20LXAC057 20NXAC038 20LXAC041 20LXAC055 Additional affected lots as of 3/17/21: 20NXAC013 20NXAC0358272 cases
Z-0817-2021NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2351-8 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.; Lot Numbers: 20LXAC097 Additional affected lot as of 3/17/21: 20NXAC033577 cases
Z-0818-2021NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3201-4 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.; Lot Numbers: 20LXAC038 20NXAC032819 cases
Z-0819-2021NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3231-1 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.; Lot Numbers: 20LXAC090 20NXAC0441006 cases
Z-0820-2021NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3251-9 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.; Lot Numbers: 20LXAC043 20LXAC044 20LXAC045 20LXAC059 20LXAC060 20LXAC079 20LXAC095 20NXAC026 Additional lots as of 3/17/21: 20LXAC078 20NXAC012 20LXAC058 20LXAC096 20NXAC01119646 cases
Z-0821-2021NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3301-2 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.; Lot Numbers: 20LXAC092 20NXAC006 20NXAC0271780 cases
Z-0822-2021NaturaLyte Liquid Acid concentrate bottles, Model Number 08-4231-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.; Lot Numbers: 20LXAC052 Additional affected lot as of 3/17/21: 20LXAC0881726 cases
Z-0823-2021NaturaLyte Liquid Acid concentrate drums, Model Number 13-1251-1 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.; Lot Numbers: 20LXAC034 20LXAC069 20NXAC04051 drums
Z-0824-2021NaturaLyte Liquid Acid concentrate drums, Model Number 13-2201-5 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.; Lot Numbers: 20LXAC030 20LXAC084 20NXAC002 20LXAC014 20NXAC01827 drums
Z-0825-2021NaturaLyte Liquid Acid concentrate drums, Model Number 13-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.; Lot Numbers: 20LXAC070 20LXAC103 20NXAC021 20LXAC100 20LXAC026 20LXAC027 20LXAC028 20LXAC029 20LXAC065 20LXAC067 20LXAC071 20NXAC001 20NXAC019 20NXAC020 20NXAC029 Additional affected lots as of 3/17/21: 20LXAC103 20LXAC082 20LXAC025 20LXAC081 20LXAC083592 drums
Z-0826-2021NaturaLyte Liquid Acid concentrate drums, Model Number 13-3251-9 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.; Lot Numbers: 20LXAC024 20LXAC072 20LXAC073 20LXAC085 20NXAC017 20NXAC030 20LXAC074 20LXAC023 20LXAC104 Additional affected lots as of 3/17/21: 20LXAC066 20LXAC089230 drums
Z-0827-2021Citrasate Liquid Acid concentrate bottles, Model Number 08-3251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.; Lot Numbers: 20LXAC051548 cases
Z-0828-2021Citrasate Liquid Acid concentrate drums, Model Number 13-2251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.; Lot Numbers: 20LXAC031 Additional affected lots as of 3/17/21: 20NXAC004 20LXAC033 20NXAC003 20LXAC032198 drums
Z-0829-2021Citrasate Liquid Acid concentrate drums, Model Number 13-3251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.; Lot Numbers: 20LXAC032 20NXAC003176 drums
Based on the official FDA remedy

What to do — step by step

  1. Check Product Lot Number

    Look for lot numbers 20LXAC034, 20LXAC069, or 20NXAC040 on the drums.

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

Distributed nationwide.

Recall timeline

FDA published this recall 2 months after the firm started it.

1. Firm started the recall: Nov 7, 202012. FDA classified it Class II: Jan 11, 202123. Published in FDA’s Enforcement Report: Jan 20, 2021320202021
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

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-0823-2021 (November 7, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0823-2021 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