⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

ICU Medical, Inc.: Plum Solo Precision IV Pump, 40001-0401

Medical DevicesSource: FDA (device) · Date: 2026-06-17

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
ICU Medical, Inc.
Product
Plum Solo Precision IV Pump, 40001-0401
Reason / hazard
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.
Classification
Class II
Status
Ongoing
Distribution / sold at
Worldwide - US Nationwide distribution in the states of ID, IL, IN, KS, MA, MD, NM, NY, PA, TN, TX and the country of Canada.
Recall initiated
2026-04-29
Code info
UDI-DI M335400011 Plum Solo Precision IV Pump v1.0.3
Product quantity
13,613
Voluntary mandated
Voluntary: Firm initiated
City
Lake Forest
State
IL
Country
United States
Event id
98872
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