FDA-Device2026-06-17Class IIPROCESSING DEFECT
ICU Medical Plum Duo Infusion Pump recalled for missing soft limit alerts
What this means
The Plum Duo Infusion Pump may fail to display alerts when medication delivery limits are exceeded. Without these warnings, clinicians may not know before the pump starts delivering the wrong amount of medication to a patient.
- If your facility uses this pump model (40002-0401), contact ICU Medical for guidance on checking your device.
- Check with your biomedical or clinical engineering team for any facility-level updates or patches.
The agency's original wording
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.
Intended for
Adults
Illnesses reported
None reported
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 Duo Infusion Pump, 40002-0401
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2312-2026More ICU Medical recalls
- FDA-Device2026-07-22ICU Medical Plum Solo Precision IV Pump v1.0.3 recalled for potential overdose risk
- FDA-Device2026-07-22ICU Medical Plum Duo Infusion Pump recalled for potential overdose risk
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