Z-1048-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- January 21, 2026
- Initiation Date
- November 21, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30 units
Product Description
Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
Reason for Recall
Emphasizing instructions for LVP duration programming located in the IFU.
Distribution Pattern
US Nationwide distribution in the states of CA, CO, FL, GA, ID, IL, MD, MI, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI, WI.
Code Information
Product Code: LVP-SW-0005; UDI: 00811505030122; Software versions 5.10.2 and prior.