# FDA recall Z-2110-2018

> **Fresenius Medical Care Renal Therapies Group, LLC** · Class II · device recall initiated 2018-05-02.

## Product

NaturaLyte¿ Liquid Acid Concentrate for Bicarbonate Dialysis, 3.43 Liters, Part Number: 08-3231-1    Product Usage:  This concentrate is formulated to be used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine. For every 45 volume parts of dialysate: 1 volume part of the NaturaLyte acid concentrate, 1.72 volume parts of FMCNA Sodium Bicarbonate Concentrate and 42.28 volume parts of Purified Water (AAMI quality) are used.

## Reason for recall

The bottles are mislabeled with an incorrect part number.

## Distribution

Worldwide Distribution - US Nationwide in the states:  CA, IA, IL, IN, KS, MD, MI, MN, MS, NE, NJ, NV, OK, PA, SD, TX, and WI.

## Key facts

- **Recall number:** Z-2110-2018
- **Recalling firm:** Fresenius Medical Care Renal Therapies Group, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-05-02
- **Report date:** 2018-06-13
- **Termination date:** 2020-05-13

- **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-2110-2018

## Citation

> AI Analytics. FDA recall Z-2110-2018. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2110-2018. Source: US FDA. Licensed CC0.

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