# FDA recall Z-1407-2022

> **ROi CPS LLC** · Class II · device recall initiated 2022-06-03.

## Product

Nonsterile convenience kits:  (1) regard Item #830099008, CV01005H - CV Part 1 Bundle; and (2) regard Item #830019017, CV00214Q - CV.

## Reason for recall

Some nonsterile components that were supposed to be sterile were packaged in nonsterile kits.

## Distribution

Distribution was made to MO.  There was no foreign/military/government distribution.

## Key facts

- **Recall number:** Z-1407-2022
- **Recalling firm:** ROi CPS LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-06-03
- **Report date:** 2022-07-27
- **Termination date:** 2023-04-14

- **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-1407-2022

## Citation

> AI Analytics. FDA recall Z-1407-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1407-2022. Source: US FDA. Licensed CC0.

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