# FDA recall Z-0101-2018

> **ICU Medical Inc** · Class II · device recall initiated 2017-10-30.

## Product

Plum 360 Infusion System, List number 30010.

## Reason for recall

(1) Under certain conditions, if a malfunction alarm occurs while the pump is in the "Paused" state waiting for the distal pressure to decrease, the pump cannot be turned off and delivery cannot be restarted until the battery is discharged or is disconnected; and (2) when the user accesses the Preventive Maintenance Screen in Service/Biomed Mode with a Total Delivery Time >1,500 hours, the user will not be able to interact with the device and the device must be power cycled.

## Distribution

Distribution was nationwide to medical facilities.  Foreign distribution was made to Canada and Australia.  Government and military distribution was also made.

## Key facts

- **Recall number:** Z-0101-2018
- **Recalling firm:** ICU Medical Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-10-30
- **Report date:** 2017-11-22
- **Termination date:** 2019-08-28

- **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-0101-2018

## Citation

> AI Analytics. FDA recall Z-0101-2018. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0101-2018. Source: US FDA. Licensed CC0.

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