# FDA recall Z-0822-2020

> **Isopure Corp** · Class II · device recall initiated 2019-04-19.

## Product

Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) with a Finish Thompson Centrifugal Pump Model #110192-3

## Reason for recall

There is a potential for an uneven plastic encapsulation of the magnet ring during the molding process and partial axial displacement. This issue could cause uneven wear during use, cause exposure of the magnet to solution, and thereby result in corrosion and the presence of iron.

## Distribution

The products were distributed to the following US states:  AL, FL, GA, MA, MD, MN, NC, NM, NY, OH, OK, TX, and VA.

## Key facts

- **Recall number:** Z-0822-2020
- **Recalling firm:** Isopure Corp
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-04-19
- **Report date:** 2020-01-29
- **Termination date:** 2020-05-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Louisville, KY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0822-2020

## Citation

> AI Analytics. FDA recall Z-0822-2020. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-0822-2020. Source: US FDA. Licensed CC0.

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