Recall Z-2724-2026 · FRN Pump, Infusion
ICU Medical, Inc.
ICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401; infusion pump
| Date | Jul 10, 2026 (initiated Jun 10, 2026) |
| Status | Open, Classified |
| Reason | In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate. |
| Root cause | Under Investigation by firm |
| Action | ICU Medical issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 06/10/2026 via hand delivered letter. The notice explained the issue, potential risk, and requested the following: "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. If the pump is in the state shown in Figures 1 and 2, do not press the Start button. Wait for the pump to complete the Cassette Test before taking further action. It is important to note that if the clinician waits for the Cassette Test |
| Quantity | 5059 units |
| Distribution | Worldwide distribution - US Nationwide and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K242114 | Plum Solo Precision IV Pump Icu Medical, Inc., Apr 2, 2025 |