{"url_path":"/fda/device/recalls/Z-2224-2026","section_key":"summary","section_title":"DEVICE Recall: Fresenius Kabi USA, LLC — Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-05-06","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2224-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Fresenius Kabi USA, LLC"},"word_count":179,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2224-2026\n\n**Recalling firm:** Fresenius Kabi USA, LLC\n**Classification:** Class I\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-05-06\n**Report date:** 2026-06-10\n\n## Product\nIvenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004\n\n## Reason\nFresenius 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.\n\n## Affected lots\nModel Number: LVP-0004; UDI-DI: 00811505030320; All Serial/Lot Numbers:\n\n## Distribution\nDomestic: CA, CO, FL, GA, ID, IL, MD, MI, MI , MN, MO, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI, WI;"}