--- title: "Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004 — FDA record Z-1313-2023 | Is It on Recall" description: "Fluid ingress that can cause a loss of electrical funtion and failure of the Set ID Sensory, resulting in the prevention of infusion or halt of infusion." url: https://isitonrecall.com/recall/fda-device-z-1313-2023-ivenix-infusion-system-iis-large-volume-pump-model-no-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 No. LVP-0004 — FDA record Z-1313-2023 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 10, 2023. 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 No. LVP-0004 - **Reason**: Fluid ingress that can cause a loss of electrical funtion and failure of the Set ID Sensory, resulting in the prevention of infusion or halt of infusion. - **Classification**: Class I - **Recalling firm**: Fresenius Kabi USA, LLC - **Quantity**: 1,546 units - **Agency-reported status**: Ongoing - **Source record identifier**: Z-1313-2023 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1313-2023%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 | UDI-DI: 00811505030320; Serial No.: 2118200008, 2118200011, 2119300411, 2119300412, 2119300414, 2119300415, 2119300416, 2119300417, 2119300418, 2119300421, 2119300422, 2119300424, 2119300426, 2119300427, 2119300428, 2119300429, 2119300430, 2119300431, 2119300432, 2119300434, 2119300435, 2119300436, 2119300437, 2119300438, 2119300439, 2119300440, 2119300442, 2124300049, 2124300051, 2124300052, 2124300053, 2124300054, 2124300058, 2124300059, 2124300060, 2124300061, 2124300062, 2124300063, 2124300064, 2124300065, 2124300066, 2124300068, 2124300069, 2124300070, 2124300072, 2124300074, 2124300075, 2124300076, 2124300077, 2124300078, 2124300080, 2124300082, 2124300083, 2124300084, 2124300085, 2124300086, 2124300087, 2124300089, 2124300090, 2124300091, 2124300093, 2124300094, 2124300096, 2124300097, 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[Read the complete list at the official source](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1313-2023%22). Match all identifying details in the current notice. A brand name alone is not enough. ## Distribution Domestic: CA, CO, NJ, WI, & UT. No foreign distribution. States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address. - [California](https://isitonrecall.com/state/california/) - [Colorado](https://isitonrecall.com/state/colorado/) - [New Jersey](https://isitonrecall.com/state/new-jersey/) - [Utah](https://isitonrecall.com/state/utah/) - [Wisconsin](https://isitonrecall.com/state/wisconsin/) ## Dates in the source - **Report date**: Apr 19, 2023 - **Recall initiation date**: Mar 10, 2023 - **Center classification date**: Apr 11, 2023 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-1313-2023%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/)