ICU Medical, Inc. recalls ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines)

Recall date

December 15, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1120-2026

FDA classification

Class II

Brand / firm

ICU Medical, Inc.

Sold / distributed

Worldwide distribution - US Nationwide and the country of Philippines.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines)