Official recall record
ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2025-12-15
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Brand on record
- ICU Medical, Inc.
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Record last checked against the registry on 2026-05-31.
Other recalls from this brand
- 2026-05-12 · US FDA — Medical Devices
Plum administration sets - 2026-05-12 · US FDA — Medical Devices
IV Sets with drip chambers - 2026-05-12 · US FDA — Medical Devices
IV Non-Dedicated Gravity Administration Sets with drip chambers
All 16 official recall notices naming ICU Medical, Inc. on this site →