{"url_path":"/fda/device/recalls/Z-3084-2026","section_key":"summary","section_title":"DEVICE Recall: Fresenius Medical Care Renal Therapies Group, LLC — 5008X Standard HD Pre-Flush    Standard Blood Tubing Set    Part Number 03-5110-6","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-08-10","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3084-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Fresenius Medical Care Renal Therapies Group, LLC"},"word_count":118,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-3084-2026\n\n**Recalling firm:** Fresenius Medical Care Renal Therapies Group, LLC\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-08-10\n**Report date:** 2026-09-09\n\n## Product\n5008X Standard HD Pre-Flush    Standard Blood Tubing Set    Part Number 03-5110-6\n\n## Reason\nHeightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia.\n\n## Affected lots\nLots 25KR01227 25NR01257  UDI-DI 00840861102556\n\n## Distribution\nWorldwide - US Nationwide distribution in the states of AL, CA, CO, FL, GA, IL, KY, LA, MA, MD, MN, MO, NC, NH, NH, NY, OH, PA, TN, TX, VA and the country of Lithuania."}