HIGH

ICU Medical Recalls Plum Duo IV Pump Due to High Hazard

ICU Medical recalled Plum Duo Precision IV Pumps on December 15, 2025, after issues with programmed flush volumes could lead to violations. The recall affects models 400020403 in the U.S. and 400021003 in the Philippines. Users must stop using the device immediately and follow manufacturer instructions.

Quick Facts at a Glance

Recall Date
December 15, 2025
Hazard Level
HIGH
Brand
ICU Medical
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message when programming a piggyback flush, which prevents the flush from being programmed.

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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About This Product

The Plum Duo Precision IV Pump is used in healthcare settings to deliver medications intravenously. It features a programmed flush feature that is intended to automatically clear the line after piggyback therapy, which is common in fluid administration.

Why This Is Dangerous

The device may improperly deliver flush volumes, leading to potential medication errors. This could result in serious health risks for patients receiving treatment.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Users must stop using the device immediately, which can disrupt patient care. The urgency of addressing this recall ensures patient safety during medication administration.

Practical Guidance

How to identify if yours is affected

  1. Check the model number on the device.
  2. Verify the software version matches 1.2.2 or 1.2.0 for affected models.
  3. Look for recall notification letters from ICU Medical.

Where to find product info

The model number and software version are typically located on the back or bottom of the IV pump.

What timeline to expect

Expect to receive instructions from ICU Medical within 4-6 weeks regarding the recall process.

If the manufacturer is unresponsive

  • Contact ICU Medical directly through their customer service line.
  • Follow up with your healthcare provider for assistance.

How to prevent similar issues

  • Always check for recalls before using medical devices.
  • Verify that the device has the latest software updates.
  • Consult healthcare professionals for device safety prior to use.

Documentation advice

Keep records of all correspondence with ICU Medical, including emails and phone call notes. Document any issues encountered with the device for future reference.

Product Details

The recall includes Plum Duo Precision IV Pumps, List Numbers: 400020403 (US), 400021003 (Philippines). The affected software versions are 1.2.2 and 1.2.0. The device has been distributed worldwide.

Key Facts

  • Recall date: December 15, 2025
  • Models affected: 400020403, 400021003
  • Classification: Class II
  • Immediate action required

Safety Guide

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

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
400020403 (US)
Software Versions: 1.2.2
400021003 (Philippines)
Software Versions: 1.2.0
Affected States
ALL
Report Date
January 28, 2026
Recall Status
ACTIVE

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