Fresenius Kabi USA, LLC: Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Fresenius Kabi USA, LLC
- Product
- Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
- Reason / hazard
- Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution in the state of Minnesota.
- Recall initiated
- 2025-09-03
- Code info
- Model Number: LVP-0004. UDI-DI: 00811505030320. Serial Numbers: 2318600378, 2321600176, 2333300359, 2403001383, 9242756430, 9243097443.
- Product quantity
- 6 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- North Andover
- State
- MA
- Country
- United States
- Event id
- 97554
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