Plum Duo Infusion System, List Number: 400020401
Pending LLM rewrite. Source: FDA_DEVICE Z-2129-2025.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
ICU Medical identified two sequences of programming events and alarm interactions that may cause the user interface to become unresponsive.
The recalled product
- Product
- Plum Duo Infusion System, List Number: 400020401
- Manufacturer
- ICU Medical, Inc.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: M335400021
Distribution
Distributed nationwide across the United States.
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