[pending] Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
Pending LLM rewrite. Source: FDA_DEVICE Z-1048-2026.
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
Emphasizing instructions for LVP duration programming located in the IFU.
The recalled product
- Product
- Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
- 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 (3)
- Product Code: LVP-SW-0005
- UDI: 00811505030122
- Software versions 5.10.2 and prior.
Distribution
Distributed nationwide across the United States.
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