[pending] Plum Duo Precision IV Pump, 40002-0403
Pending LLM rewrite. Source: FDA_DEVICE Z-2313-2026.
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 Precision IV Pump, 40002-0403
- 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 M335400031 Plum Duo Precision IV Pump v1.2.3
Distribution
Distributed nationwide across the United States.
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