FDA Enforcement
Class II
Ongoing
Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
Recall: Z-1048-2026
·
Reported January 21, 2026
Enforcement
- Recall Number
- Z-1048-2026
- Event ID
- 98106
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Fresenius Kabi USA, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 21, 2026
- Initiation Date
- November 21, 2025
- Classification Date
- January 12, 2026
- Address
- 50 High St Ste 50, North Andover, MA, 01845-2620, United States
Description
Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
Reason
Emphasizing instructions for LVP duration programming located in the IFU.
Code Info
Product Code: LVP-SW-0005; UDI: 00811505030122; Software versions 5.10.2 and prior.
Distribution
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.
Quantity
30 units