Recall archive / FDA device enforcement
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patie... — FDA record Z-0885-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 14, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.
- Reason
- Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
- Classification
- Class I
- Recalling firm
- Fresenius Kabi USA, LLC
- Quantity
- 30 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0885-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Software Versions 5.10.1 and prior; UDI: 00811505030122. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US (Domestic) distribution: CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA & WI.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Dec 24, 2025
- Recall initiation date
- Nov 14, 2025
- Center classification date
- Dec 16, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.