--- title: "Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004 — FDA record Z-0763-2025 | Is It on Recall" description: "Potential pneumatic valve failure that may cause the LVP to stop an active infusion and/or could prevent the pump from being used." url: https://isitonrecall.com/recall/fda-device-z-0763-2025-ivenix-infusion-system-iis-large-volume-pump-model-number-lvp-0004/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004 — FDA record Z-0763-2025 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 Dec 6, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **Product**: Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004 - **Reason**: Potential pneumatic valve failure that may cause the LVP to stop an active infusion and/or could prevent the pump from being used. - **Classification**: Class I - **Recalling firm**: Fresenius Kabi USA, LLC - **Quantity**: 1,520 units - **Agency-reported status**: Ongoing - **Source record identifier**: Z-0763-2025 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0763-2025%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | Model Number: LVP-0004, UDI Number: 00811505030320. 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agency lot list is longer than this excerpt. [Read the complete list at the official source](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0763-2025%22). Match all identifying details in the current notice. A brand name alone is not enough. ## Distribution US distribution to states of: ID, MN, NV, TX, VA, WI. States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address. - [Idaho](https://isitonrecall.com/state/idaho/) - [Minnesota](https://isitonrecall.com/state/minnesota/) - [Nevada](https://isitonrecall.com/state/nevada/) - [Texas](https://isitonrecall.com/state/texas/) - [Virginia](https://isitonrecall.com/state/virginia/) - [Wisconsin](https://isitonrecall.com/state/wisconsin/) ## Dates in the source - **Report date**: Jan 15, 2025 - **Recall initiation date**: Dec 6, 2024 - **Center classification date**: Jan 8, 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. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0763-2025%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [Fresenius Kabi USA, LLC records](https://isitonrecall.com/brand/fresenius-kabi-usa-llc/)