Recall Z-1048-2026
Fresenius Kabi USA, LLC · initiated November 21, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
Codes / lots: Product Code: LVP-SW-0005; UDI: 00811505030122; Software versions 5.10.2 and prior.
Reason for recall
Emphasizing instructions for LVP duration programming located in the IFU.
FDA-determined 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.
Details
- Recall number
- Z-1048-2026
- Initiated
- November 21, 2025
- Posted by FDA
- January 12, 2026
- Product code
- FRN – Pump, Infusion
- Quantity
- 30 units
- 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.
- Recalling firm
- Fresenius Kabi USA, LLC, North Andover, MA