Plum Duo Infusion Pump, 40002-0401
FDA Recall Z-2312-2026 · Posted 2026-06-05
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Recalling FirmICU Medical, Inc.
Recall StatusOpen, Classified
Product CodeFRN
Date Initiated2026-04-29
Product Quantity13,613
Reason for Recall
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.
Firm 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.
Root Cause
Software Design Change
Distribution Pattern
Worldwide - US Nationwide distribution in the states of ID, IL, IN, KS, MA, MD, NM, NY, PA, TN, TX and the country of Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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