BEUDAMED
    FDA Recall Open, Classified

    Plum Duo Infusion Pump, 40002-0401

    Recall: Z-2312-2026 · Initiated April 29, 2026

    Recall

    Recall Number
    Z-2312-2026
    Event Number
    98872
    Firm
    ICU Medical, Inc.
    FEI Number
    3013319212
    Product Code
    FRN
    Status
    Open, Classified
    Root Cause
    Software Design Change
    Initiated
    April 29, 2026
    Posted
    June 5, 2026
    Address
    600 N Field Dr, Lake Forest, IL, 60045-4835

    Description

    Plum Duo Infusion Pump, 40002-0401

    Reason

    Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.

    Action

    On April 29, 2026, the firm notified consignees via letters titled "URGEND MEDICAL DEVICE CORRECTION." Customers were instructed to identify all affected pumps in their possession and ensure all users or potential users of the pumps are immediately made aware of the notification. During bolus programming, clinicians should check whether the soft limit override icon is displayed next to the bolus dose entry field on the programming screen. If the pump displays the icon, the clinician should review the program and make any necessary adjustments before confirming the program. The firm is developing a software update to correct the issue and will notify customers when it is available.

    Distribution

    Worldwide - US Nationwide distribution in the states of ID, IL, IN, KS, MA, MD, NM, NY, PA, TN, TX and the country of Canada.

    Quantity

    13,613