# FDA recall Z-1739-2022

> **Isopure Corp** · Class II · device recall initiated 2022-07-26.

## Product

Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is intended to be used in  Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of Hemodialysis  patients    Model: ACDS MD704262

## Reason for recall

Acidified Concentrate Distribution System potential electrical safety hazard may result in electric shock, arching

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1739-2022
- **Recalling firm:** Isopure Corp
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-07-26
- **Report date:** 2022-09-21
- **Termination date:** 2024-05-31

- **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-1739-2022

## Citation

> AI Analytics. FDA recall Z-1739-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1739-2022. Source: US FDA. Licensed CC0.

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