Plum Duo Infusion System, List Number: 400020401

ICU Medical identified two sequences of programming events and alarm interactions that may cause the user interface to become unresponsive.

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 prevent unintended interruptions. 3. If the pump becomes unresponsive, exchange the pump and reprogram. Follow-up Actions by ICU Medical: ICU Medical will develop a patch to correct this issue for Plum Duo. ICU Medical will contact you to schedule the software update for your pumps if needed. https://icumed.custhelp.com/app/market-action For any questions regarding this action Technical Support 1-(800)-241-4002, option 3 [email protected]