Recall archive / FDA device enforcement
LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0. — FDA record Z-1484-2024
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 Mar 7, 2024. 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
- LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.
- Reason
- Software has anomalies that have the potential to cause underdose, overdose, or delay in therapy which could lead to serious patient harm or death.
- Classification
- Class I
- Recalling firm
- Fresenius Kabi USA, LLC
- Quantity
- 17 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1484-2024
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 | Product LVP-SW-0004; UDI-DI 00811505030122. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Distribution: CA, CO, ID, MI, NE, NJ, NV, OK, TX, UT, 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
- Apr 17, 2024
- Recall initiation date
- Mar 7, 2024
- Center classification date
- Apr 11, 2024
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.