FDA-Device2025-08-13Class I
Plum Duo Infusion System, List Number: 400020401
Hazard
ICU Medical identified two sequences of programming events and alarm interactions that may cause the user interface to become unresponsive.
Sold states
US Nationwide.
Affected count
4677 units
Manufactured in
600 N Field Dr, N/A, Lake Forest, IL, United States
Products
Plum Duo Infusion System, List Number: 400020401
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2129-2025More ICU Medical, Inc. recalls
- FDA-Device2026-06-17ICU Medical Plum Duo Precision IV Pump recalled for missing soft limit alerts
- FDA-Device2026-06-17ICU Medical Plum Duo Infusion Pump recalled for missing soft limit alerts
- FDA-Device2026-06-17ICU Medical Plum Solo Precision IV Pump recalled for missed soft limit alerts
- FDA-Device2026-05-27ICU Medical ChemoLock oncology infusion sets recalled for potential leakage during therapy
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