The Recall Desk
HighFDA (Devices)·Z-0833-2021·Announced 2021-01-20

Fresenius Naturalyte Liquid Acid concentrate bottles recalled for conductivity deviation

Fresenius Medical Care is recalling Naturalyte Liquid Acid concentrate bottles due to deviations in sodium conductivity and calcium concentration.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device used in hemodialysis with deviations in critical electrolyte concentrations (sodium and calcium). This fits the rubric criterion for 'risk-of-harm products where injury has not yet been reported' (Score 3), as no specific injuries or illnesses are cited in the source text.

Plain-English summary

Fresenius Medical Care Holdings, Inc. is recalling Naturalyte Liquid Acid concentrate bottles (Product Code 08-2251-0). These products are used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in compatible 45X dilution three-stream artificial kidney (hemodialysis) machines.

The recall is due to a deviation in conductivity for sodium level that exceeds 0.6mS/cm from the theoretical conductivity or approximately 6mEq/L of sodium from prescriptions. Additionally, the calcium concentration in the affected units is below manufacturing specification.

The recall involves 3,083 cases distributed nationwide in the United States. Affected lot numbers include 20LXAC076, 20LXAC077, 20LXAC091, 20LXAC101, 20NXAC010, and additional lots identified as of March 17, 2021. Users should stop using the affected product and contact the manufacturer for instructions.

The recalled product

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.
Manufacturer
Fresenius Medical Care Holdings, Inc.
Category
Medical Device — Dialysis Supplies
Hazard
Affected units
3,083

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 11 recalled by Fresenius Medical Care Holdings, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 11 products in this recall →

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