# FDA recall Z-1376-2021

> **ROi CPS LLC** · Class II · device recall initiated 2021-03-04.

## Product

Regard, Item Number 830067009, custom cardiovascular procedure kit

## Reason for recall

ROi CPS, LLC has become aware, through a vendor issued urgent medical device recall notice, that drapes contained within select Regard customer procedure trays may have slits in the product that may lead to a breach in the sterile barrier between fluid in the basin and the slush/warming equipment.

## Distribution

US Nationwide distribution in the state of Missouri.

## Key facts

- **Recall number:** Z-1376-2021
- **Recalling firm:** ROi CPS LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-03-04
- **Report date:** 2021-04-14

- **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-1376-2021

## Citation

> AI Analytics. FDA recall Z-1376-2021. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1376-2021. Source: US FDA. Licensed CC0.

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