[pending] Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Pending LLM rewrite. Source: FDA_DEVICE Z-0848-2026.
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
Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.
The recalled product
- Product
- Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
- Manufacturer
- Fresenius Kabi USA, LLC
- 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)
- Model Number: LVP-0004. UDI-DI: 00811505030320.
Distribution
Distributed nationwide across the United States.
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