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ICU Medical, Inc. recalls ICU Medical Plum Solos, Item number 400011001; infusion pump
Recalled June 25, 2025 · FDA recall Z-1991-2025 · ICU Medical
Hazard
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. · FDA Class II
Units
214 units
Sold at
Worldwide - US Nationwide distribution in the states of FL, KY, VA, MS, MA, PA, NY, CA, IA and the country of Philippines.
Description
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.
Product
ICU Medical Plum Solos, Item number 400011001; infusion pump
Manufacturer(s)
ICU Medical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →