Recall
FDAHealthDecember 15, 2025

ICU Medical, Inc. — ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines)

⚠️ 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.

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
December 15, 2025

Worldwide distribution - US Nationwide and the country of Philippines.

What's affected?

Product
ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines)
Lot code
400020403 (US), Software Versions: 1.2.2; 400021003 (Philippines), Software Versions: 1.2.0

Additional details

400020403 (US), Software Versions: 1.2.2; 400021003 (Philippines), Software Versions: 1.2.0

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated

View original FDA notice →

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