HIGHFDA DEVICE

Plum Duo Precision IV Pump, 40002-0403

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.

ICU MedicalHealth & Personal CareMedical DevicesUDI-DI M335400031 Plum Duo Precision IV Pump v1.2.3

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
April 29, 2026
Status
ACTIVE

Quick Facts at a Glance

Recall Date
April 29, 2026
Hazard Level
HIGH
Brand
ICU Medical
Geographic Scope
1 states

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
ICU Medical
Model numbers
UDI-DI M335400031 Plum Duo Precision IV Pump v1.2.3
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    April 29, 2026

  2. Reported by FDA DEVICE

    June 17, 2026

  3. RecallRadar source check

    June 23, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

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.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact ICU Medical, Inc. or your healthcare provider for instructions. Notification method: Letter

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Full Description

Plum Duo Precision IV Pump, 40002-0403. Reason: 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. Quantity: 13,613. 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.

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: How to Get Refunds and Replacements

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Product Classification

Product Details

Model Numbers
UDI-DI M335400031 Plum Duo Precision IV Pump v1.2.3
Affected States
ALL
Report Date
June 17, 2026
Recall Status
ACTIVE

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