ICU Medical, Inc. recalls ICU Medical Plum Solos, Item number 400011001; infusion pump

Recall date

April 22, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1991-2025

FDA classification

Class II

Brand / firm

ICU Medical, Inc.

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

ICU Medical Plum Solos, Item number 400011001; infusion pump