# FDA recall Z-0832-2022

> **InfuTronix LLC** · Class II · device recall initiated 2021-10-19.

## Product

Nimbus PainPro Ambulatory Infusion Pumps with software version v4, Model Number IT1072, sold as kit IT1075-DUKE-HSP, IT1076-DUKE-HSP and IT1077-DUKE-HSP

## Reason for recall

An unreleased Version 4 Protocol Library was installed on Nimbus PainPro (H) infusion pumps in error that may impact patient safety if used on patients.

## Distribution

US Nationwide distribution in the states of NC and OH.

## Key facts

- **Recall number:** Z-0832-2022
- **Recalling firm:** InfuTronix LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-10-19
- **Report date:** 2022-04-06

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0832-2022

## Citation

> AI Analytics. FDA recall Z-0832-2022. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-0832-2022. Source: US FDA. Licensed CC0.

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