FDADecember 15, 2025device

ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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 to do

FDA enforcement status: Ongoing

Brands named

icu medicalicu

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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