Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Pending LLM rewrite. Source: FDA_DEVICE Z-0848-2026.
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
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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