- Recalling firm
- ICU Medical, Inc.
- 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.
- Affected products (lot / model / serial)
- UDI-DI M335400031 Plum Duo Precision IV Pump v1.2.3
- Units affected
- 13,613
- 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.
- Firm location
- Lake Forest, IL, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2313-2026
- Recall initiated
- April 29, 2026
- FDA classification date
- June 5, 2026
- FDA report date
- June 17, 2026
- FDA event ID
- 98872
- Last updated on HTM Vibe
- July 23, 2026