{"url_path":"/fda/device/recalls/Z-2210-2026","section_key":"summary","section_title":"DEVICE Recall: ICU Medical, Inc. — Oncology Kit w/60\" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros; ChemoLock; Syringe Transfer Set w/MicroClave, ChemoLock Port, REF: CL3960","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-03-24","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2210-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"ICU Medical, Inc."},"word_count":157,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2210-2026\n\n**Recalling firm:** ICU Medical, Inc.\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-03-24\n**Report date:** 2026-05-27\n\n## Product\nOncology Kit w/60\" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros; ChemoLock; Syringe Transfer Set w/MicroClave, ChemoLock Port, REF: CL3960\n\n## Reason\nOncology sets/closed system transfer devices with extension sets may leak resulting in therapy delayed if noticed and corrected during setup, but if the leak occurs during therapy this may result in therapy interruption with the potential for the patient to receive less infusion solution than intended. Exposure of hazardous substances to the patient, caregiver, or pharmacy technician is possible.\n\n## Affected lots\nUDI-DI: 10887709083278. Lots: 13919794, 14134777, 14196319\n\n## Distribution\nUS Nationwide distribution in the states of GA, MA, OH, NC, CA, ND, MI, TX, FL, AR, CT, PA, WA, WI, CO, VT, NY, NH, KY, IA, KS, AL, NM, IL, MO, NJ."}