ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number 400020403; infusion pump
FDA device recall Z-2723-2026 · posted 2026-07-10 · Open, Classified
Recall details
- Recalling firm
- ICU Medical, Inc.
- Reason for recall
- In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.
- Action taken
- ICU Medical issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 06/10/2026 via hand delivered letter. The notice explained the issue, potential risk, and requested the following: "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. If the pump is in the state shown in Figures 1 and 2, do not press the Start button. Wait for the pump to complete the Cassette Test before taking further action. It is important to note that if the clinician waits for the Cassette Test to complete (and the START button is only pressed once), this potential scenario does not occur. If the pump displays a green background on the line with active animation indicating delivery is occurring and the VTBI is not decrementing, stop delivery and restart the line to resolve this issue. Complete and return the attached Customer Response Form to ICUMedMarketActionsTeam@icumed.com within 10 days of receipt to acknowledge your understanding of this notification." For further inquiries: For any questions regarding this action: https://icumed.custhelp.com/app/market-action. Additional technical information or assistance: Technical Support, 1-(800)-241-4002, option 3 or tsc.support@icumed.com. To report adverse events or product complaints: Global Complaint Management: 1-844-654-7780 (M-F, 8:00 am 5:00 pm CT) or ProductComplaintsPP@icumed.com.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- FRN
- Quantity affected
- 12525 units
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Date initiated
- 2026-06-10
- Date posted
- 2026-07-10
- Location
- Lake Forest, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Plum Duo™ Infusion System (K223607) | Icu Medical, Inc. | 2023-08-24 |