Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
- Company
- Fresenius Kabi Usa, Llc
- Recall Initiated
- November 21, 2025
- Posted
- January 12, 2026
- Recall Number
- Z-1048-2026
- Quantity
- 30 units
- Firm Location
- North Andover, MA
Reason for Recall
Emphasizing instructions for LVP duration programming located in the IFU.
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.
Lot / Code Info
Product Code: LVP-SW-0005; UDI: 00811505030122; Software versions 5.10.2 and prior.
Root Cause
Use error
Action Taken
An URGENT MEDICAL DEVICE CORRECTION notification dated 11/21/25 was sent to consignees notifying them of this safety alert. The notification reiterates instructions for administering infusions included in the device's IFU. Fresenius Kabi asks consignees to disseminate the notification to all users and any facilities where devices may have been further distributed for their awareness. Consignees with any questions are to contact Customer Support by email at Ivenix_support@fresenius-kabi.com or by phone at 1-855-354-6387.