Z-1119-2026 Class II Ongoing
FDA device recall Z-1119-2026 was initiated by ICU Medical, Inc. on Dec 15, 2025 and is designated Class II. 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… The recall status is ongoing.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 28, 2026
- Initiation Date
- Dec 15, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
Product Description
ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (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.
Distribution Pattern
Worldwide distribution - US Nationwide and the country of Philippines.
Code Information
400020403 (US), Software Versions: 1.2.2; 400021003 (Philippines), Software Versions: 1.2.0
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1119-2026
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026