Recall Z-1119-2026 · FRN Pump, Infusion
ICU Medical, Inc.
ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines)
| Date | Jan 16, 2026 (initiated Dec 15, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Software design |
| Action | ICU Medical issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 12/15/2025 via mail, email, telephone, or hand delivery. The notice explained the issue, potential risk and requested the following: "Actions for Users Identify all affected infusion pumps in your possession and ensure all users or potential users of these pumps are immediately made aware of this notification and the sequence of events described. If you do experience this issue, the following mitigations can be performed: " To program the piggyback flush, the clinician must either a) clear infusion program da |
| Distribution | Worldwide distribution - US Nationwide and the country of Philippines. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K242115 | Plum Duo Precision IV Pump Icu Medical, Inc., Apr 2, 2025 |