—#217669

Product

ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K223607
Affected lot / code info: 400020401 (US), Software Versions: 1.1.1, 1.1.2, 1.1.3, 1.1.4 400021001 (Philippines), Software Versions: 1.1.0

Why it was recalled

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.

Root cause (FDA determination)

Software design

Action the firm took

ICU 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.

Recalling firm

Firm: ICU Medical, Inc.
Address: 600 N Field Dr, Lake Forest, Illinois 60045-4835

Distribution

Distribution pattern: Worldwide distribution - US Nationwide and the country of Philippines.

Timeline

Recall initiated: 2025-12-15
Posted by FDA: 2026-01-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #217669. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.