Z-1118-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- January 28, 2026
- Initiation Date
- December 15, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (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
400020401 (US), Software Versions: 1.1.1, 1.1.2, 1.1.3, 1.1.4 400021001 (Philippines), Software Versions: 1.1.0