Z-0378-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 5, 2025
- Initiation Date
- September 3, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 units
Product Description
Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Reason for Recall
Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.
Distribution Pattern
US Nationwide distribution in the state of Minnesota.
Code Information
Model Number: LVP-0004. UDI-DI: 00811505030320. Serial Numbers: 2318600378, 2321600176, 2333300359, 2403001383, 9242756430, 9243097443.