Lower risk Medical device recall · FDA · Published November 23, 2020

Fresenius Naturalyte Liquid Acid Concentrate Bottles Recall: Sodium Level Risk

Fresenius Medical Care recalls Naturalyte Liquid Acid concentrate bottles (Product Code 08-2201-5) due to sodium level deviations that could affect dialysis treatment safety.

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

🇺🇸 FDA recall #Z-0832-2021Medical device Fresenius Medical Care ›

Lower-risk recall

The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification.

Take action

Contact the company

Recalling firmFresenius Medical Care Holdings, Inc.920 Winter St Bld 950 · Waltham, MA 02451-1521

✎ GovInfoNow plain-language explainer

Fresenius Medical Care is recalling Naturalyte Liquid Acid concentrate bottles used in hemodialysis machines because they may have incorrect sodium levels. This could lead to unsafe dialysis treatments if the bottles are not properly calibrated. Read more at govinfonow.com/recall/63799-fresenius-naturalyte-liquid-acid-concentrate-bottles-recall-sodium-level-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/63799-fresenius-naturalyte-liquid-acid-concentrate-bottles-recall-sodium-level-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0832-2021

Cite this page

“Fresenius Naturalyte Liquid Acid Concentrate Bottles Recall: Sodium Level Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63799-fresenius-naturalyte-liquid-acid-concentrate-bottles-recall-sodium-level-risk. Based on FDA recall #Z-0832-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0832-2021%22&limit=1).

The FDA announced on November 23, 2020, that Fresenius Medical Care Holdings, Inc. is recalling Naturalyte Liquid Acid concentrate bottles due to conductivity and calcium concentration deviations. This Class II recall affects Product Code 08-2201-5.

How to tell if you have it

Brand: Fresenius Medical Care
Product: Naturalyte Liquid Acid concentrate bottles
Product Code: 08-2201-5
Lot Numbers: 20LXAC086, 20LXAC099, 20NXAC014, 20LXAC061, 20LXAC062

The hazard

According to the FDA, the deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity or approximately 6mEq/L of sodium from prescriptions. Additionally, the calcium concentration is below manufacturing specification.

Context

GovInfoNow's records show Fresenius Medical Care Holdings, Inc. has 44 other recalls on record since April 14, 2014. Recent related actions include a May 12, 2026 recall for Bicarby Dialysate leaks and a May 11, 2026 recall for 5008X Blood Tubing Set online port errors. Other recent recalls of similar products include Fresenius NaturaLyte Liquid Acid Concentrate Recall (July 14, 2026) and Fresenius Medical Care Citrasate Liquid Acid Concentrate Recall (July 14, 2026).

How to tell if you have this one

Check for Product Code 08-2201-5 on the bottle. Affected lots include 20LXAC086, 20LXAC099, 20NXAC014, and additional lots listed as of March 17, 2021.

Brand
Fresenius Medical Care
Category
Medical device

FDA recall event · 11 products

All 11 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 number	Product, codes & lots	Quantity
Z-0831-2021	Naturalyte Liquid Acid concentrate bottles, Product Code 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: 20LXAC063 20NXAC008 Additional Affected lots as of 3/17/21: 20NXAC005 20LXAC098 20NXAC039 20NXAC008 20LXAC063	1686 cases
Z-0832-2021	Naturalyte Liquid Acid concentrate bottles, Product Code 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: 20LXAC086 20LXAC099 20NXAC014 Additional Affected lots as of 3/17/21: 20LXAC061 20LXAC062 20LXAC099 20LXAC086 20NXAC014	2246 cases
Z-0833-2021	Naturalyte Liquid Acid concentrate bottles, Product Code 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: 20LXAC076 20LXAC077 20LXAC091 20LXAC101 20NXAC010 Additional Affected lots as of 3/17/21: 20LXAC053 20LXAC047 20LXAC054 20LXAC049 20NXAC016 20LXAC094 20NXAC024 20NXAC025 20LXAC091 20LXAC101 20LXAC077 20LXAC048 20NXAC010 20LXAC076	3083 cases
Z-0834-2021	Citrasate Liquid Acid concentrate bottles, Product Code 08-2251-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: 20NXAC007 Additional Affected lots as of 3/17/21: 20NXAC007	278 cases
Z-0835-2021	Naturalyte Liquid Acid concentrate bottles, Product Code 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: 20NXAC013 20NXAC035 Additional Affected lots as of 3/17/21: 20LXAC056 20LXAC041 20LXAC055 20LXAC057 20NXAC013 20NXAC035	1426 cases
Z-0836-2021	Naturalyte Liquid Acid concentrate bottles, Product Code 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: 20NXAC033 Additional Affected lots as of 3/17/21: 20LXAC097 20NXAC033	123
Z-0837-2021	Naturalyte Liquid Acid concentrate bottles, Product Code 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: 20LXAC058 20LXAC078 20LXAC096 20NXAC011 20NXAC012 Additional Affected lots as of 3/17/21: 20LXAC060 20NXAC026 20LXAC045 20LXAC043 20LXAC078 20NXAC012 20LXAC058 20LXAC096 20NXAC011 20LXAC059 20LXAC044 20LXAC079	5079 cases
Z-0838-2021	Naturalyte Liquid Acid concentrate bottles, Product Code 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: 20LXAC088 Additional Affected lots as of 3/17/21: 20LXAC088 20LXAC052	912 cases
Z-0839-2021	Naturalyte Liquid Acid concentrate drums, Product Code 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: 20LXAC025 20LXAC081 20LXAC082 20LXAC083 Additional Affected lots as of 3/17/21: 20LXAC029 20NXAC021 20LXAC026 20LXAC065 20LXAC028 20NXAC029 20LXAC071 20LXAC103 20LXAC027 20LXAC070 20LXAC067 20NXAC019 20LXAC082 20LXAC025 20LXAC081 20LXAC083	224 drums
Z-0840-2021	Naturalyte Liquid Acid concentrate drums, Product Code 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: 20LXAC066 20LXAC089 Additional Affected lots as of 3/17/21: 20LXAC066 20LXAC073 20LXAC074 20LXAC024 20LXAC023 20LXAC072 20LXAC085 20LXAC089	2 drums
Z-0841-2021	Citrasate Liquid Acid concentrate drums, Product Code 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: 20LXAC033 20NXAC004 Additional Affected lots as of 3/17/21: 20LXAC031 20NXAC004 20LXAC033 20NXAC003 20LXAC032	2 drums

Based on the official FDA remedy

What to do — step by step

Check Product Code
Look for Product Code 08-2201-5 on the bottle label to confirm if it's affected.

Where it went and when

Where it was distributed

Distributed nationwide.

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 58 days after the firm started it.

Nov 23, 2020Firm started the recall
Jan 11, 2021FDA classified it Class II
Jan 20, 2021Published in FDA’s Enforcement Report

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

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Do I need to stop using this product?

The recall does not require immediate discontinuation; check the product code and lot number to determine if it's affected.

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Link to this recall

<a href="https://govinfonow.com/recall/63799-fresenius-naturalyte-liquid-acid-concentrate-bottles-recall-sodium-level-risk">Fresenius Naturalyte Liquid Acid Concentrate Bottles Recall: Sodium Level Risk (GovInfoNow)</a>

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-0832-2021 (November 23, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0832-2021 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.