Medical device recalls High risk

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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