FDA Medical Device · Z-1120-2026

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

Class II · Ongoing

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.

Affected lots / codes — check yours against this400010401 (US), Software Versions: 1.0.2; 400011001 (Philippines), Software Versions: 1.0.0

Recalling firm: ICU Medical, Inc., Lake Forest, IL
Classification: Class II (temporary or reversible harm possible)
Status: Ongoing
Quantity: —
Distribution: Worldwide distribution - US Nationwide and the country of Philippines.
Recall initiated: December 15, 2025
Classified: January 16, 2026
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1120-2026%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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