Z-0848-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- December 10, 2025
- Initiation Date
- November 3, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15,862 units
Product Description
Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Reason for Recall
Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.
Distribution Pattern
US Nationwide distribution in the sates of CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, UT, VA, WA, WI.
Code Information
Model Number: LVP-0004. UDI-DI: 00811505030320.