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U.S. Department of Health and Human Services

Class 2 Device Recall ICU Medical

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 Class 2 Device Recall ICU Medicalsee related information
Date Initiated by FirmDecember 15, 2025
Date PostedJanuary 16, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1118-2026
Recall Event ID 98128
510(K)NumberK223607 
Product Classification Pump, infusion - Product Code FRN
ProductICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)
Code Information 400020401 (US), Software Versions: 1.1.1, 1.1.2, 1.1.3, 1.1.4 400021001 (Philippines), Software Versions: 1.1.0
Recalling Firm/
Manufacturer		 ICU Medical, Inc.
600 N Field Dr
Lake Forest IL 60045-4835
For Additional Information ContactICU Medical Customer Help
844-654-7780
Manufacturer Reason
for Recall		Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message when programming a piggyback flush, which prevents the flush from being programmed.
FDA Determined
Cause 2		Software design
ActionICU Medical issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 12/15/2025 via mail, email, telephone, or hand delivery. The notice explained the issue, potential risk and requested the following: "Actions for Users 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 and the sequence of events described. If you do experience this issue, the following mitigations can be performed: " To program the piggyback flush, the clinician must either a) clear infusion program data and power cycle the pump or b) obtain a replacement pump. " The clinician may also continue with the piggyback infusion without using the piggyback flush feature. To manually flush the downstream line, attach and program a flush syringe or bag on Line 2 to flush the fluid from the downstream line at the piggyback rate before restarting the primary line." For device correction inquiries, contact https://icumed.custhelp.com/app/market-action. For technical support, contact: 1-(800)-241-4002, option 3; tsc.support@icumed.com. For complaints, contact: 1-844-654-7780 (M-F, 8:00 am 5:00 pm CT) or ProductComplaintsPP@icumed.com.
DistributionWorldwide distribution - US Nationwide and the country of Philippines.
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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