[pending] Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Pending LLM rewrite. Source: FDA_DEVICE Z-0378-2026.
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 issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.
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 (6)
- Model Number: LVP-0004. UDI-DI: 00811505030320. Serial Numbers: 2318600378
- 2321600176
- 2333300359
- 2403001383
- 9242756430
- 9243097443.
Distribution
Distributed nationwide across the United States.
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