{ "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": "106532", "product_res_number": "Z-0726-2012", "event_date_initiated": "2011-12-30", "event_date_posted": "2012-01-12", "recall_status": "Terminated", "event_date_terminated": "2016-02-10", "res_event_number": "60804", "product_code": "MSD", "k_numbers": [ "K101843" ], "product_description": "Angiodynamics DuraMax VP Vascpak Catheter Kit 15.5F x 24cm Chronic Hemodialysis VascPak (with Cuff 19cm from Tip) --- Catalog No. [REF] 10302818 --- MANUFACTURED IN USA AngioDynamics, Inc., 603 Queensbury Avenue, Queensbury, NY USA 12804\n\nProduct Usage: indicated for use in attaining long-term vascular access for Hemodialysis and Apheresis.", "code_info": "FG Lot Numbers: 541561, 554930", "firm_fei_number": "3008319439", "recalling_firm": "Angiodynamics Worldwide Headquarters", "address_1": "14 Plaza Drive", "city": "Latham", "state": "NY", "postal_code": "12110-3421", "additional_info_contact": "David Greer\n518-795-1676", "reason_for_recall": "The securement cuff on the hemodialysis catheter has the potential to detach from the shaft.", "root_cause_description": "Nonconforming Material/Component", "action": "AngioDynamics sent an Urgent - Medical Device Recall letter dated December 30, 2011, via certified mail to all affected customers. The letter identified the affected product, the problem, and the actions to be taken. Customers were instructed to examine inventory, segregate the recalled lots and return remaining inventory to the firm. The letter states that replacement product will be shipped upon receipt and confirmation of the returned product. Customers were advised to complete the Recall Reply Form included and fax to DuraMax Hemodialysis Catheter Recall Coordinator at 518-798-1360. \n\nFor questions contact your local representative or call the Customer Service Manger at ANGIODYNAMICS Customer Service at 1-800-772-6446.", "product_quantity": "142 units", "distribution_pattern": "Worldwide Distribution - USA (Nationwide)", "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" ] } } ] }