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U.S. Department of Health and Human Services

Class 2 Device Recall Plum Duo Infusion Pump

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 Class 2 Device Recall Plum Duo Infusion Pumpsee related information
Date Initiated by FirmApril 29, 2026
Date PostedJune 05, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2312-2026
Recall Event ID 98872
510(K)NumberK223607 
Product Classification Pump, infusion - Product Code FRN
ProductPlum Duo Infusion Pump, 40002-0401
Code Information UDI-DI M335400021 Plum Duo Infusion Pump v1.2.3
FEI Number 3013319212
Recalling Firm/
Manufacturer		 ICU Medical, Inc.
600 N Field Dr
Lake Forest IL 60045-4835
For Additional Information ContactTechnical Support
800-241-4002 Ext. 3
Manufacturer 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.
FDA Determined
Cause 2		Software Design Change
ActionOn 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.
Quantity in Commerce13,613
DistributionWorldwide - US Nationwide distribution in the states of ID, IL, IN, KS, MA, MD, NM, NY, PA, TN, TX and the country of Canada.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FRN
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