Z-1048-2026 Class II Ongoing
FDA device recall Z-1048-2026 was initiated by Fresenius Kabi USA, LLC on Nov 21, 2025 and is designated Class II. Reason for recall: Emphasizing instructions for LVP duration programming located in the IFU. The recall status is ongoing. Affected quantity: 30 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 21, 2026
- Initiation Date
- Nov 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.