[pending] Plum Duo Infusion Pump, 40002-0401
Pending LLM rewrite. Source: FDA_DEVICE Z-2312-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- Plum Duo Infusion Pump, 40002-0401
- 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 Plum Duo Infusion Pump v1.2.3
Distribution
Distributed nationwide across the United States.
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