# FDA recall Z-1990-2025

> **ICU Medical, Inc.** · Class II · device recall initiated 2025-04-22.

## Product

ICU Medical Plum Duo, Item numbers:  1) 400020401, 2) 400021001  , and 3) 400021003; infusion pump

## Reason for recall

Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may result in bypassing the Maximum Dose Limit alert.  The Maximum Dose Limit is set in the LifeShield Drug Library Manager (DLM) within the LifeShield Medication Management Safety Software and specifies the highest dose at which the pump can be programmed for weight or BSA (body surface area) based medication rulesets. The limit can be configured for Dose, Loading Dose, and Bolus Dose.

## Distribution

Worldwide - US Nationwide distribution in the states of FL, KY, VA, MS, MA, PA, NY, CA, IA and the country of Philippines.

## Key facts

- **Recall number:** Z-1990-2025
- **Recalling firm:** ICU Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-04-22
- **Report date:** 2025-06-25

- **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-1990-2025

## Citation

> AI Analytics. FDA recall Z-1990-2025. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-1990-2025. Source: US FDA. Licensed CC0.

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