{"url_path":"/fda/device/recalls/Z-2274-2026","section_key":"summary","section_title":"DEVICE Recall: Fresenius Kabi USA, LLC — The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-02-04","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2274-2026%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":90,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2274-2026\n\n**Recalling firm:** Fresenius Kabi USA, LLC\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-02-04\n**Report date:** 2026-06-10\n\n## Product\nThe Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.\n\n## Reason\nPotential for the Cassette Loading Lever to break.\n\n## Affected lots\nModel Number: LVP-0004. UDI-DI: 00811505030320\n\n## Distribution\nUS Nationwide distribution in the states of CA, CO, FL, GA, ID, IL, MA, MD, ME, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI."}