# FDA recall Z-1010-2018

> **Fresenius Medical Care Renal Therapies Group, LLC** · Class II · device recall initiated 2017-09-29.

## Product

NaturaLyte¿ Liquid Acid Concentrate 2.0 mEq/L,  Model # 08-2251-0  3.43 liter bottle    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.

## Reason for recall

The label specifies the potassium concentration is 2.0 mEq/L. Some of the product in the affected lot was  found to have a potassium concentration of 2.25 mEq/L.

## Distribution

US Distribution to states of: CA, FL, KS, LA, and TX.

## Key facts

- **Recall number:** Z-1010-2018
- **Recalling firm:** Fresenius Medical Care Renal Therapies Group, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-09-29
- **Report date:** 2018-03-21
- **Termination date:** 2018-08-09

- **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-1010-2018

## Citation

> AI Analytics. FDA recall Z-1010-2018. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/Z-1010-2018. Source: US FDA. Licensed CC0.

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