# FDA recall Z-1542-2021

> **ROi CPS LLC** · Class II · device recall initiated 2021-03-26.

## Product

Regard Dressing Change Tray

## Reason for recall

ChloraPrep applicators in the kit can grow organisms that can result in a breach of the applicators package integrity.

## Distribution

US Nationwide distribution in the state of Louisiana.

## Key facts

- **Recall number:** Z-1542-2021
- **Recalling firm:** ROi CPS LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-03-26
- **Report date:** 2021-05-19
- **Termination date:** 2023-01-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Republic, MO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1542-2021

## Citation

> AI Analytics. FDA recall Z-1542-2021. Retrieved 2026-09-08 from https://api.ai-analytics.org/recall/Z-1542-2021. Source: US FDA. Licensed CC0.

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