Recall Z-1094-2026 · FRN Pump, Infusion
ICU Medical, Inc.
Plum Duo Infusion System, List Number 40002-04-01
| Date | Jan 15, 2026 (initiated Dec 15, 2025) |
| Status | Open, Classified |
| Reason | ICU Medical received one lot of defective primary speakers from our supplier that may fail to produce an audible sound. If the primary speaker in your Plum Duo Infusion Pump fails, the pump may not produce audible alarms, alerts, or provide audible feedback for touchscreen inputs. |
| Root cause | Nonconforming Material/Component |
| Action | An URGENT: MEDICAL DEVICE CORRECTION dated 12/15/25 was sent to customers. Actions for Users: 1. Identify all affected infusion pumps in your possession and ensure all users or potential users of these pumps are immediately informed of this notice. If the devices are used at another location, please ensure this communication is delivered to that location. 2. If the primary speaker fails, obtain another pump to continue the infusion. Remove the affected pump from clinical use until the speaker can be replaced. 3. Complete and return the attached Customer Response Form to icumedmarketactionstea |
| Quantity | 423 units |
| Distribution | Worldwide - US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K223607 | Plum Duo Infusion System Icu Medical, Inc., Aug 24, 2023 |