# FDA recall Z-0835-2021

> **Fresenius Medical Care Holdings, Inc.** · Class II · device recall initiated 2020-11-23.

## 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.

## Reason for 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.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-0835-2021
- **Recalling firm:** Fresenius Medical Care Holdings, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-11-23
- **Report date:** 2021-01-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Waltham, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0835-2021

## Citation

> AI Analytics. FDA recall Z-0835-2021. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0835-2021. Source: US FDA. Licensed CC0.

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