Company: ICU Medical, Inc.
Date of Enforcement Report: 6/18/2025
Class: II

PRODUCT

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

Recall Number:

Z-1990-2025

REASON:

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.

RECALLING FIRM/MANUFACTURER:

ICU Medical, Inc.

VOLUME:

1701 units

DISTRIBUTION:

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