# FDA recall Z-3031-2017

> **ICU Medical Inc** · Class II · device recall initiated 2017-06-15.

## Product

Plum 360 Infusion System

## Reason for recall

Potential for the Connectivity Engine Module of the affected unit to disengage from the main chassis, causing the unit to shut down without an alarm notification. This would delay initiation of therapy or interrupt an infusion.

## Distribution

Worldwide Distribution - USA (nationwide) Distribution to the states of including Puerto Rico : AL, AR, AZ, CA, FL, GA, HI, IA, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, MS, MT, NE, NH, NJ, NM, NY, OH, PA, SD, TN, TX, VA, WA, WI, WY and District of Columbia., and to the countries of :  Australia, Canada, Chile, Colombia, France, Greece, Hong Kong, Ireland, Italy, Jordan, Kuwait, Mexico, New Zealand, Oman, Peru, Philippines, Poland, Saudi Arabia, Spain, Turkey, United Arab Emirates, and United Kingdom.

## Key facts

- **Recall number:** Z-3031-2017
- **Recalling firm:** ICU Medical Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-06-15
- **Report date:** 2017-08-23
- **Termination date:** 2020-04-17

- **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-3031-2017

## Citation

> AI Analytics. FDA recall Z-3031-2017. Retrieved 2026-07-02 from https://api.ai-analytics.org/recall/Z-3031-2017. Source: US FDA. Licensed CC0.

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