PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: January 28, 2026 Initiated: December 15, 2025 #Z-1120-2026

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.

Details

Recalling Firm
ICU Medical, Inc.
Distribution
Worldwide distribution - US Nationwide and the country of Philippines.
Location
Lake Forest, IL

Frequently Asked Questions

What product was recalled?
ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines). Recalled by ICU Medical, Inc..
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on January 28, 2026. Severity: Moderate. Recall number: Z-1120-2026.