FDA-Device2026-06-17Class IIPROCESSING DEFECT
ICU Medical Plum Solo Precision IV Pump recalled for missed soft limit alerts
OTHERNationwide distribution
ICU Medical Plum Solo IV Pump recalled for missed alerts
The Plum Solo Precision IV Pump may fail to display a soft limit alert under certain conditions, preventing clinicians from being notified of dosage limit violations before the pump starts delivery. This could result in incorrect medication doses being administered.
- If you operate or manage this pump in a clinical setting, contact ICU Medical for guidance on affected units and available corrections.
- Review your facility's pump inventory against the affected model number 40001-0401 and UDI-DI M335400011.
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.
Sold states
Worldwide - US Nationwide distribution in the states of ID, IL, IN, KS, MA, MD, NM, NY, PA, TN, TX and the country of Canada.
Affected count
13,613
Manufactured in
600 N Field Dr, N/A, Lake Forest, IL, United States
Products
Plum Solo Precision IV Pump, 40001-0401
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2311-2026More ICU Medical, Inc. recalls
- FDA-Device2026-06-17ICU Medical Plum Duo Precision IV Pump recalled for missing soft limit alerts
- FDA-Device2026-06-17ICU Medical Plum Duo Infusion Pump recalled for missing soft limit alerts
- FDA-Device2026-05-27ICU Medical ChemoLock oncology infusion sets recalled for potential leakage during therapy
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