# FDA recall Z-1811-2024

> **OptumHealth Care Solutions LLC** · Class I · device recall initiated 2024-04-18.

## Product

Optum Nimbus II Plus, Model number AAA-00170; Ambulatory Infusion Pump

## Reason for recall

Nimbus II Plus, Infusion Pump Systems, manufactured by InfuTronix, are being removed the from the market due to multiple potential failure modes, including battery failure, upstream occlusion, system errors, drug product leakage, high or low flow rate, or damaged pump housing.

## Distribution

US Nationwide Distribution

## Key facts

- **Recall number:** Z-1811-2024
- **Recalling firm:** OptumHealth Care Solutions LLC
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-04-18
- **Report date:** 2024-05-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Marietta, GA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1811-2024

## Citation

> AI Analytics. FDA recall Z-1811-2024. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1811-2024. Source: US FDA. Licensed CC0.

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