ICU Medical, Inc. recalls Plum Duo Infusion System, List Number: 400020401
- Recall date
- July 11, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2129-2025
- FDA classification
- Class I
- Brand / firm
- ICU Medical, Inc.
- Sold / distributed
- US Nationwide.
Why it was recalled
ICU Medical identified two sequences of programming events and alarm interactions that may cause the user interface to become unresponsive.
Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.
What was recalled
Plum Duo Infusion System, List Number: 400020401
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