FDAHealthApril 29, 2026
ICU Medical, Inc. — Plum Solo Precision IV Pump, 40001-0401
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- April 29, 2026
Worldwide - US Nationwide distribution in the states of ID, IL, IN, KS, MA, MD, NM, NY, PA, TN, TX and the country of Canada.
What's affected?
- Product
- Plum Solo Precision IV Pump, 40001-0401
- Brand
- ICU Medical, Inc.
- Lot code
- UDI-DI M335400011 Plum Solo Precision IV Pump v1.0.3
Additional details
UDI-DI M335400011 Plum Solo Precision IV Pump v1.0.3
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 13,613.
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