ICU Medical, Inc. recalls ICU Medical Plum Duo Infusion Pump
- Recalling company
- ICU Medical, Inc.
- Product
- ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)
- Reason
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Dec 15, 2025
- Reported
- Jan 28, 2026
- Distribution
- Worldwide distribution - US Nationwide and the country of Philippines.
- Status
- Ongoing
- Lot / codes
- 400020401 (US), Software Versions: 1.1.1, 1.1.2, 1.1.3, 1.1.4 400021001 (Philippines), Software Versions: 1.1.0
- Company location
- Lake Forest, IL
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-1118-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-1118-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.