BEUDAMED
    FDA Recall Open, Classified

    Plum Duo Infusion System, List Number 40002-04-01

    Recall: Z-1094-2026 · Initiated December 15, 2025

    Recall

    Recall Number
    Z-1094-2026
    Event Number
    98129
    Firm
    ICU Medical, Inc.
    FEI Number
    3013319212
    Product Code
    FRN
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    December 15, 2025
    Posted
    January 15, 2026
    Address
    600 N Field Dr, Lake Forest, IL, 60045-4835

    Description

    Plum Duo Infusion System, List Number 40002-04-01

    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.

    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 [email protected] within 10 days of receipt to acknowledge your understanding of this notification. 4. If you have distributed affected products to your customers, please immediately forward this notice to them. Request that they complete the response form and return it to [email protected]. Follow-up Actions by ICU Medical: ICU Medical will address the issue described in this letter through a software update. This update will ensure the backup buzzer will always generate audio for alarms, malfunctions and alerts. ICU Medical will contact you to schedule the software correction for this issue. Device Correction Inquiries https://icumed.custhelp.com/app/market-action For any questions regarding this action

    Distribution

    Worldwide - US Nationwide distribution.

    Quantity

    423 units