FDAHealthSeptember 3, 2025
Fresenius Kabi USA, LLC — Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
⚠️ Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- September 3, 2025
US Nationwide distribution in the state of Minnesota.
What's affected?
- Product
- Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
- Lot code
- Model Number: LVP-0004. UDI-DI: 00811505030320. Serial Numbers: 2318600378, 2321600176, 2333300359, 2403001383, 9242756430, 9243097443.
Additional details
Model Number: LVP-0004. UDI-DI: 00811505030320. Serial Numbers: 2318600378, 2321600176, 2333300359, 2403001383, 9242756430, 9243097443.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 6 units.
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