# FDA recall Z-2465-2020

> **ROi CPS LLC** · Class II · device recall initiated 2020-05-19.

## Product

Isolation Droplet Bundle Kit

## Reason for recall

Roi CPS, LLC has become aware of a labeling error that affects select custom procedure kits. The kits are labeled with an expiration date that is later than that of the soonest kit component to expire in the kits.

## Distribution

Domestic distribution only to: MO and LA.

## Key facts

- **Recall number:** Z-2465-2020
- **Recalling firm:** ROi CPS LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-05-19
- **Report date:** 2020-07-08
- **Termination date:** 2020-09-01

- **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-2465-2020

## Citation

> AI Analytics. FDA recall Z-2465-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2465-2020. Source: US FDA. Licensed CC0.

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