Recalling firm
ICU Medical, Inc.
Product type
Device
Status
Ongoing
Report date
2026-06-17
Distribution
Worldwide - US Nationwide distribution in the states of ID, IL, IN, KS, MA, MD, NM, NY, PA, TN, TX and the country of Canada.
Firm state
IL
Product quantity
13,613
Initiated by
Voluntary: Firm initiated
Reason for recall
Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.
Product description
Plum Solo Precision IV Pump, 40001-0401
Code / lot info
UDI-DI M335400011 Plum Solo Precision IV Pump v1.0.3
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.