# FDA recall Z-2685-2024

> **ROi CPS LLC** · Class II · device recall initiated 2024-06-17.

## Product

Regard Kit containing the Microtek decanter

## Reason for recall

Decanters may have pin holes and tears in sterile packaging that cannot be identified visually.

## Distribution

US Nationwide distribution in the state of MO.

## Key facts

- **Recall number:** Z-2685-2024
- **Recalling firm:** ROi CPS LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-06-17
- **Report date:** 2024-08-28

- **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-2685-2024

## Citation

> AI Analytics. FDA recall Z-2685-2024. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2685-2024. Source: US FDA. Licensed CC0.

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