Ivenix Infusion System (IIS): recall status

Notice names this product. Fresenius Kabi USA’s Ivenix Infusion System (IIS) is named in FDA Class I recall Z-2224-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: Fresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the Ivenix LVP may cause damage to internal components that may not be apparent or readily visible and the devices therefore remained in service. More specifically, drops or jarring on a hard surface can cause the touchscreen input cable to loosen, resulting in unintended touchscreen behavior on the LVP, including random screen touches and/or lack of screen responsiveness to user input. Under the reported failure condition, unintended touch inputs may register at arbitrary screen locations without user interaction. These inputs occur intermittently and without a predictable pattern. Identifying details: Model Number: LVP-0004; UDI-DI: 00811505030320; All Serial/Lot Numbers:. Units affected: 18,444. Status: Ongoing.