Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Pending LLM rewrite. Source: FDA_DEVICE Z-0378-2026.
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
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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