Recall Z-2129-2025 · FRN Pump, Infusion
ICU Medical, Inc.
Plum Duo Infusion System, List Number: 400020401
| Date | Aug 6, 2025 (initiated Jul 11, 2025) |
| Status | Open, Classified |
| Reason | ICU Medical identified two sequences of programming events and alarm interactions that may cause the user interface to become unresponsive. |
| Root cause | Under Investigation by firm |
| Action | An "URGENT: MEDICAL DEVICE CORRECTION" notification letter dated 7/11/25 was sent to customers. The letter described the product, problem and actions to be taken. Actions for Users: 1. 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. 2. To stop an infusion, ensure that users carefully attend to the "CONFIRM STOP" message that appears after pressing the STOP button. The "CONFIRM STOP" message includes a yes/no selection to confirm the intent to stop the infusion, thereby helping to pr |
| Quantity | 4677 units |
| Distribution | US Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K223607 | Plum Duo Infusion System Icu Medical, Inc., Aug 24, 2023 |