ICU Medical Plum Solo Precision IV Pump recalled for missed soft limit 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.
From the FDA notice · Read the official notice ↗ · All ICU Medical recalls
What to do
- 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.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Plum Solo Precision IV Pump, 40001-0401
- Sold in
- Nationwide
- Made for
- All ages (under 100 years)
This recall covers 3 products — see all of them.
Details
- Units affected
- 13,613
- Illnesses reported
- None reported
- Manufactured in
- 600 N Field Dr, N/A, Lake Forest, IL, United States
- Classification
- Class II
- Recall number
- Z-2311-2026
In the FDA's words
- Description
- 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. UDI-DI M335400011 Plum Solo Precision IV Pump v1.0.3 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. Affected quantity: 13,613
- 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.
3 products in this recall
ICU Medical Plum infusion pumps recalled for missed dosing alerts
ICU Medical is recalling three Plum infusion pump models, covering 13,613 units each. Under certain conditions, the pump may not show a soft limit alert or warn the clinician of a soft limit violation before delivery starts, which could lead to under- or over-delivery of medication. No injuries have been reported.
The agency lists each product separately. Check every one you might have.
- Plum Solo Precision IV Pump, 40001-0401 (this page)Z-2311-2026 · 13,613
- Plum Duo Infusion Pump, 40002-0401Z-2312-2026 · 13,613
- Plum Duo Precision IV Pump, 40002-0403Z-2313-2026 · 13,613
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ModerateFDASep 23, 2026