[pending] The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.
Pending LLM rewrite. Source: FDA_DEVICE Z-2274-2026.
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
Potential for the Cassette Loading Lever to break.
The recalled product
- Product
- The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). 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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