ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines)
FDA Recall #Z-1120-2026 — Class II — December 15, 2025
Product Description
ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines)
Reason for Recall
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.
Recalling Firm
ICU Medical, Inc. — Lake Forest, IL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Distribution
Worldwide distribution - US Nationwide and the country of Philippines.
Code Information
400010401 (US), Software Versions: 1.0.2; 400011001 (Philippines), Software Versions: 1.0.0
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated