# FDA recall Z-0171-2020

> **ICU Medical Inc** · Class II · device recall initiated 2018-08-01.

## Product

Plum 360 Infusion System With MedNet/ Smart Card Plug And Play Module, Model # 30010.    Infusion pump.

## Reason for recall

A software malfunction of the infuser when used with a MedNet Custom Drug Library (CDL).  When a new CDL is downloaded and installed on the infuser the infuser can become inoperable and show a blank screen on the User Interface.

## Distribution

US nationwide distribution, and  Canada

## Key facts

- **Recall number:** Z-0171-2020
- **Recalling firm:** ICU Medical Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-08-01
- **Report date:** 2019-10-30
- **Termination date:** 2021-04-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lake Forest, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0171-2020

## Citation

> AI Analytics. FDA recall Z-0171-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0171-2020. Source: US FDA. Licensed CC0.

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