# FDA recall Z-1859-2021

> **Medivators, Inc.** · Class II · device recall initiated 2021-04-20.

## Product

Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbonate in a compatible artificial kidney (hemodialysis) machine.

## Reason for recall

The lot may have experienced an anomaly during the manufacturing process, that could lead to an out of specification concentrate formulation.

## Distribution

US Nationwide distribution in the states of IA, IL, MN, ND, NY, OH, SD,WI.

## Key facts

- **Recall number:** Z-1859-2021
- **Recalling firm:** Medivators, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-04-20
- **Report date:** 2021-06-23
- **Termination date:** 2024-07-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Plymouth, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1859-2021

## Citation

> AI Analytics. FDA recall Z-1859-2021. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1859-2021. Source: US FDA. Licensed CC0.

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