← FDA ENFORCEMENT
Z-1048-2026Class II
Fresenius Kabi USA, LLC
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Recalling firm
Fresenius Kabi USA, LLC
Product type
Device
Status
Ongoing
Report date
2026-01-21
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.
Firm state
MA
Product quantity
30 units
Initiated by
Voluntary: Firm initiated
Reason for recall
Emphasizing instructions for LVP duration programming located in the IFU.
Product description
Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
Code / lot info
Product Code: LVP-SW-0005; UDI: 00811505030122; Software versions 5.10.2 and prior.
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →