{"url_path":"/fda/device/recalls/Z-2156-2026","section_key":"summary","section_title":"DEVICE Recall: ARROW INTERNATIONAL, LLC — Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-I","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-04-10","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2156-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"ARROW INTERNATIONAL, LLC"},"word_count":166,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2156-2026\n\n**Recalling firm:** ARROW INTERNATIONAL, LLC\n**Classification:** Class I\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-04-10\n**Report date:** 2026-05-20\n\n## Product\nArrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-I\n\n## Reason\n16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, vessel wall injury.\n\n## Affected lots\nREF/UDI-DI/Lot:  CS-15242-I/ 30801902195280/33F23G0536; CS-15282-I/30801902195532/33F23C0877, 33F24A0281, 33F24H0041; CS-15322-I/30801902197451/33F23G0545\n\n## Distribution\nWorldwide distribution: US nationwide and countries of:  AE, AL, AR, AT, AU, BE, BG, BS, BR, BW, CA, CH, CL, CN, CO, CZ, DE, EC, EE, ES, FR, GB, GR, GT, HU, ID, IE, IN, IT, JP, KW, KZ, LB, LT, LU, MN, MZ, NA, NL, NO, NP, NZ, PA, PE, PF, PH, PL, PT, QA, RO, RS, RU, SA, SG, SL, SK, SZ, TH, TN, TR, TT, UA, VN, ZA, ZM, and ZW"}