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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Fresenius Medical Care Holdings, Inc.: 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.

Agency Publication Date: January 11, 2021
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Affected Products

Product: 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

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Product: 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

Lot Numbers:
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Product: 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

Lot Numbers:
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Product: 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

Lot Numbers:
Numbers
Product: 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

Lot Numbers:
Numbers
Product: 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

Lot Numbers:
Numbers
Product: 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

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Product: 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

Lot Numbers:
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Product: 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

Lot Numbers:
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Product: 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

Lot Numbers:
Numbers
Product: 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

Lot Numbers:
Numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 86939
Status: Active
Manufacturer: Fresenius Medical Care Holdings, Inc.
Manufactured In: United States
Units Affected: 11 products (1686 cases; 2246 cases; 3083 cases; 278 cases; 1426 cases; 123; 5079 cases; 912 cases; 224 drums; 2 drums; 2 drums)
Agency Last Updated: April 14, 2021

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.