# FDA recall Z-1381-2022

> **Ivenix, Inc.** · Class II · device recall initiated 2022-04-22.

## Product

Ivenix Infusion System (IIS)

## Reason for recall

Downstream occlusion alarm is sometimes immediately followed by a pump problem alarm.

## Distribution

US Nationwide distribution in the states of NJ and WI.

## Key facts

- **Recall number:** Z-1381-2022
- **Recalling firm:** Ivenix, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-04-22
- **Report date:** 2022-07-20
- **Termination date:** 2024-05-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** North Andover, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1381-2022

## Citation

> AI Analytics. FDA recall Z-1381-2022. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-1381-2022. Source: US FDA. Licensed CC0.

---

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