Recall archive / FDA device enforcement
Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0 — FDA record Z-0002-2023
Reported terminated
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 Sep 8, 2022. 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-0004 version 5.2.0
- Reason
- The display screen may become frozen and unresponsive to user input, triggering an alarm that is evidenced by a buzzer sound and flashing red LEDs as a secondary notification. However, as the screen goes blank it does not indicate an alarm condition or respond. This issue leads to temporary cessation of flow of a medication or fluid, requiring immediate intervention by the clinician.
- Classification
- Class I
- Recalling firm
- Fresenius Kabi USA, LLC
- Quantity
- 4 instances
- Agency-reported status
- Terminated
- Source record identifier
- Z-0002-2023
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 | UDI-DI: 00811505030122 version 5.2.0 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Domestic distribution to NJ and 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
- Oct 12, 2022
- Recall initiation date
- Sep 8, 2022
- Center classification date
- Oct 6, 2022
- Termination date
- Sep 10, 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.