# FDA recall Z-2430-2023

> **ICU Medical Inc** · Class II · device recall initiated 2023-07-13.

## Product

Plum 360 Infusion System, List Numbers:  300100405, 300100409, 300100413, 300100414, 300100415, 300100418, 300100451, 300100452, 300100453, 300100481, 300100483, 300100613, 300101013, 300101113, 300101114, 300101313, 300101379, 300102213, 300102713, 300102913, 300103413, 300103414, 300104213, 300105413, 300105713, 300106313, 300106513, 300106581, 300107813, 300107814, 300108513, 300108813, 300108814, 300109913;  infusion pump

## Reason for recall

Due to a manufacturing defect of a supplier provided component, there is a potential that the audible signal for an alarm may not sound under certain conditions.

## Distribution

Worldwide

## Key facts

- **Recall number:** Z-2430-2023
- **Recalling firm:** ICU Medical Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-07-13
- **Report date:** 2023-08-30

- **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-2430-2023

## Citation

> AI Analytics. FDA recall Z-2430-2023. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2430-2023. Source: US FDA. Licensed CC0.

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