{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 4 } }, "results": [ { "cfres_id": "219684", "product_res_number": "Z-2156-2026", "event_date_initiated": "2026-04-10", "event_date_posted": "2026-05-13", "recall_status": "Open, Classified", "res_event_number": "98745", "product_code": "MSD", "k_numbers": [ "K111117" ], "product_description": "Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-I", "code_info": "REF/UDI-DI/Lot: \nCS-15242-I/ 30801902195280/33F23G0536;\nCS-15282-I/30801902195532/33F23C0877, 33F24A0281, 33F24H0041;\nCS-15322-I/30801902197451/33F23G0545", "firm_fei_number": "3013162291", "recalling_firm": "ARROW INTERNATIONAL, LLC", "address_1": "3015 Carrington Mill Blvd", "city": "Morrisville", "state": "NC", "postal_code": "27560-5437", "additional_info_contact": "Customer Service\n866-396-2111", "reason_for_recall": "16F 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.", "root_cause_description": "Nonconforming Material/Component", "action": "On 4/10/2026, recall notices were mailed to customers who were informed of the following\n\nArrow International LLC is recalling product due to the Merit Medical Systems, Inc. recall of the Merit 16F Dual-Valved Splitable Sheath Introducer component, which is included in impacted Arrow Hemodialysis Kits & Sets.\n\nCustomers were asked to do the following:\n1) Users should cease use and distribution of affected product and immediately quarantine the affected product.\n2) Complete and return the Acknowledgement Form, see link: https://fca.myteleflex.com/en/recall/000605\n3) This notice should be passed on to all persons who need to be aware within your organization or to any organization where the potentially affected devices have been transferred.\n\nIn addition, distributors were asked to do the following:\n- Provide a copy of this field safety notice to all customers who have received impacted product. Each of your customers is then required to complete the Acknowledgement Form and return it to you as their distributor.\n\nShould you require further information or support concerning this issue, please contact Customer Service via email (Recalls@teleflex.com), phone (1-866-396-2111), or FAX (1-855-419-8507).", "product_quantity": "285", "distribution_pattern": "Worldwide 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", "openfda": { "k_number": [ "K200627", "K143567", "K040402", "K111372", "K981365", "K994105", "K012562", "K022000", "K022678", "K171571", "K062671", "K123196", "K053589", "K100169", "K032061", "K043292", "K130851", "K020936", "K131260", "K051748", "K070572", "K133796", "K111817", "K092205", "K131814", "K141363", "K060155", "K013160", "K203575", "K051584", "K033294", "K041006", "K040666", "K130192", "K110936", "K001633", "K140492", "K002901", "K040736", "K111117", "K111651", "K073092", "K121848", "K981994", "K161026", "K040509", "K091506", "K171618", "K173805", "K040318", "K040992", "K040492", "K203767", "K063431", "K113487", "K972207", "K102238", "K040260", "K141051", "K062901", "K043272", "K041559", "K010306", "K042016", "K030983", "K090101", "K091760", "K111900", "K010567", "K182443", "K023847", "K210461", "K040078", "K012948", "K003207", "K080400", "K063441", "K190527", "K012365", "K140884", "K073093", "K090528", "K173667", "K022662", "K030020", "K060972", "K101843", "K130889", "K033676", "K040328", "K051280", "K102043", "K011916", "K021212", "K021759", "K092597", "K151967", "K030502", "K032712", "K121933", "K211410", "K010399", "K982333", "K072499", "K071422", "K042672", "K041914", "K020465", "K060288", "K002902", "K971925", "K022905", "K042858", "K030277", "K202150", "K981125", "K123943", "K090148", "K241581", "K982326", "K020315", "K202176", "K071202", "K023023" ], "device_name": "Catheter, Hemodialysis, Implanted", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.5540", "device_class": "2", "registration_number": [ "3005987240", "3015225571", "2030624", "1282497", "3011137372", "3013557562", "1833566", "3004134316", "9611665", "1061124", "3006950086", "2518902", "3010882065", "9680794", "3012536737", "1722746", "3007544634", "3011642792", "3011534620", "3033589330", "3009211636", "1644312", "3030574705", "9610849", "3008998256", "1319639", "3004111573", "2183744", "3002807314", "3016727301", "3035111606", "2030598", "1625425", "3006942602", "3017210488", "1721676", "3012050423", "3013750125", "3015309643", "3003915875", "2020394", "3014461810", "3006082230", "3007137787", "2528981", "2527072", "3008110587", "1018233", "3010041511", "9617592", "3006260740", "3015453963", "1724474", "3015859709", "1721504" ], "fei_number": [ "3005987240", "3015225571", "3000206435", "1282497", "3002468371", "3013557562", "1000306216", "3004134316", "3005747797", "3006950086", "2518902", "3012536737", "3007544634", "3011642792", "3011534620", "3033589330", "3009211636", "3030574705", "1000518731", "1000117748", "3008998256", "3004111573", "2183744", "3002807314", "3016727301", "3035111606", "3006097687", "1000138054", "3002807095", "1625425", "3003094851", "3006942602", "1721676", "3012050423", "3017210488", "3013750125", "3003737899", "3015309643", "3003915875", "2020394", "3002807391", "3014461810", "3006082230", "3007137787", "2528981", "2527072", "3008110587", "1018233", "3010041511", "3006260740", "1000512168", "3015453963", "3015859709", "1721504", "1000115408" ] } } ] }