# FDA recall Z-0315-2024

> **ROi CPS LLC** · Class II · device recall initiated 2023-09-21.

## Product

Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit

## Reason for recall

Specific Regard kits contain the Gentige Chest Drain Products being recalled by Gentige.  The Instructions for Use (IFU) for the chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube connections with single collection chamber chest drains.

## Distribution

MO

## Key facts

- **Recall number:** Z-0315-2024
- **Recalling firm:** ROi CPS LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-09-21
- **Report date:** 2023-11-22

- **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-0315-2024

## Citation

> AI Analytics. FDA recall Z-0315-2024. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0315-2024. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*