FDA-Device2025-06-25Class II
ICU Medical Plum Solos, Item number 400011001; infusion pump
ICU Medical, Inc.
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.
Sold states
Worldwide - US Nationwide distribution in the states of FL, KY, VA, MS, MA, PA, NY, CA, IA and the country of Philippines.
Affected count
214 units
Manufactured in
600 N Field Dr, N/A, Lake Forest, IL, United States
Products
ICU Medical Plum Solos, Item number 400011001; infusion pump
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1991-2025Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief