{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "103837", "product_res_number": "Z-0589-2012", "event_date_initiated": "2011-01-24", "event_date_posted": "2012-01-11", "recall_status": "Terminated", "event_date_terminated": "2016-02-02", "res_event_number": "59833", "product_code": "MSD", "k_numbers": [ "K080400", "K101843" ], "product_description": "DURAMAX 15.5 F x 32 cm Chronic Hemodialysis Catheter Set (With Cuff 27 cm from Tip), DuraMax Stacked Tip 32 cm Str. Basic Kit, Catalog No./REF 10302805, STERILE --- AngioDynamics, Inc. 603 Queensbury Avenue, Queensbury, NY 12804 USA\n\nThe AngioDynamics DuraMax Chronic Hemodialysis Catheter is indicated for use in attaining long-term vascular access for Hemodialysis and apheresis.", "code_info": "Lots 527842, C28715", "firm_fei_number": "1319211", "recalling_firm": "Angiodynamics, Inc.", "address_1": "603 Queensbury Avenue", "city": "Queensbury", "state": "NY", "postal_code": "12804", "additional_info_contact": "S. Michael Sharp, PhD, FRAPS\n518-795-1123", "reason_for_recall": "AngioDynamics received customer complaints for breakage of the tunneler sleeve during product use.", "root_cause_description": "Nonconforming Material/Component", "action": "The firm, AngioDynamics, sent an \"URGENT: MEDICAL DEVICE RECALL\" letter dated January 28, 2011 and response form via Certified Mail, Return Receipt Requested, to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to identify and segregate the recalled lots; complete and return the enclosed DuraMax HemoDialysis Catheter Recall Reply Form via fax to: Attn: DuraMax HemoDialysis Catheter Recall Coordinator at 518-798-1360 (even if they don't have any product); and do not use the affected product, return and ship the recalled product to ANGIODYNAMICS (replacement product will be shipped upon receipt and confirmation of the returned product). \n\nIf the customers are in immediate need for replacement product, they should fax the completed Recall Reply Form, along with a copy of the product label, to Customer Service at (518) 798-1360 or call us at (800) 772-6446, x1358 or x1363.\n\nIf you have any additional questions or concerns or need more detailed instruction on how to comply with this notice, please do not hesitate to contact your local sales representative or call ANGIODYNAMICS customer service at 1-800-772-6446 or email to: customerservice@angiodynamics.com.", "product_quantity": "33 units", "distribution_pattern": "Nationwide distribution.", "openfda": { "k_number": [ "K040402", "K003207", "K971925", "K023023", "K001633", "K041914", "K012562", "K123196", "K042672", "K010567", "K994105", "K202150", "K013160", "K190527", "K040992", "K111372", "K161026", "K073092", "K030983", "K113487", "K073093", "K040260", "K151967", "K010399", "K091760", "K111117", "K062901", "K002902", "K130192", "K060155", "K111817", "K090528", "K200627", "K020936", "K022678", "K063441", "K033294", "K030020", "K173667", "K171571", "K123943", "K210461", "K062671", "K032712", "K080400", "K241581", "K063431", "K110936", "K051584", "K100169", "K022905", "K982326", "K030502", "K040492", "K040509", "K040736", "K011916", "K023847", "K032061", "K020465", "K111900", "K102043", "K091506", "K051748", "K041559", "K012365", "K211410", "K072499", "K022662", "K002901", "K140492", "K030277", "K141051", "K043292", "K121933", "K133796", "K981125", "K090101", "K140884", "K130889", "K092205", "K111651", "K982333", "K092597", "K121848", "K071422", "K053589", "K042016", "K021759", "K203767", "K040328", "K071202", "K051280", "K022000", "K060288", "K130851", "K012948", "K101843", "K173805", "K202176", "K010306", "K042858", "K143567", "K060972", "K041006", "K981994", "K040078", "K102238", "K182443", "K040666", "K090148", "K043272", "K171618", "K141363", "K070572", "K040318", "K021212", "K972207", "K131814", "K981365", "K033676", "K203575", "K131260", "K020315" ], "device_name": "Catheter, Hemodialysis, Implanted", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.5540", "device_class": "2", "registration_number": [ "3006942602", "3015859709", "3030574705", "3015453963", "3004134316", "2030598", "1018233", "1833566", "3010882065", "2518902", "3009211636", "3017210488", "3005987240", "1644312", "3033589330", "3012536737", "3004111573", "3011642792", "3015309643", "3006082230", "1721504", "3008110587", "1282497", "3015225571", "3016727301", "3014461810", "1721676", "2183744", "3012050423", "1319639", "3008998256", "3006950086", "9610849", "9617592", "3003915875", "2020394", "1722746", "2030624", "9680794", "3002807314", "3010041511", "1724474", "2527072", "9611665", "3011137372", "1061124", "3013557562", "2528981", "3006260740", "3011534620", "3007137787", "1625425", "3013750125", "3035111606", "3007544634" ], "fei_number": [ "3006942602", "3015859709", "3030574705", "3015453963", "1000117748", "1000138054", "3004134316", "3005747797", "1018233", "2518902", "3009211636", "3017210488", "3005987240", "1000115408", "3033589330", "3006097687", "3012536737", "3004111573", "3011642792", "3015309643", "3006082230", "1721504", "3008110587", "3002807391", "1282497", "3015225571", "3016727301", "3014461810", "1721676", "3003094851", "2183744", "3012050423", "3008998256", "3006950086", "1000306216", "3003737899", "1000512168", "3003915875", "3000206435", "2020394", "3002468371", "3002807314", "3002807095", "1000518731", "3010041511", "2527072", "3013557562", "2528981", "3006260740", "3011534620", "3007137787", "1625425", "3013750125", "3035111606", "3007544634" ] } } ] }