{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "150499", "product_res_number": "Z-0404-2017", "event_date_initiated": "2016-10-13", "event_date_created": "2016-11-14", "recall_status": "Terminated", "event_date_terminated": "2022-02-10", "res_event_number": "75492", "product_code": "FAD", "k_numbers": [ "K983498" ], "product_description": "BARD INLAY Ureteral Stent with Suture, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.", "code_info": "Product Codes: 776400, 776600, 776700, and 776800.", "firm_fei_number": "1018233", "recalling_firm": "C.R. Bard, Inc.", "address_1": "8195 Industrial Blvd NE", "city": "Covington", "state": "GA", "postal_code": "30014-1497", "additional_info_contact": "Michael Wolfe\n770-784-6220", "reason_for_recall": "Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the presence of a knot if significant resistance is encountered during attempts at removal.", "root_cause_description": "Labeling Change Control", "action": "Bard Medical sent an Urgent: Medical Device Communication Letter dated October 13, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.\n\nAction required:\n\nExamine your inventory and identify any product subject to this notification. If you have any remaining inventory, include a copy of this communication with the unit(s) for future use.\n\nIf you may have further distributed or transferred this product, please identify the respective organizations and notify them at once of this communication. Your notification to these organizations may be enhanced by including a copy of this product communication letter.\n\nThis notification should be carried out to the user level.\n\nThis product notification is being made with the knowledge of the Food and Drug administration.\n\nWe appreciate your cooperation and assistance in dealing with this matter and sincerely apologize for any inconvenience that may result from this action.\n\nFor further questions, please call (770) 784-6220.", "product_quantity": "75,089 units", "distribution_pattern": "U.S. Nationwide.", "openfda": { "k_number": [ "K013784", "K930733", "K850175", "K833782", "K946296", "K923394", "K982974", "K865085", "K854908", "K925282", "K200260", "K981491", "K952513", "K830884", "K905505", "K030503", "K162109", "K141344", "K894357", "K173734", "K905289", "K820870", "K163399", "K213444", "K010002", "K033210", "K961371", "K913928", "K941952", "K191446", "K973504", "K072293", "K863492", "K930882", "K151051", "K213185", "K862539", "K211934", "K831857", "K243039", "K910691", "K904231", "K043193", "K082805", "K180057", "K170010", "K251890", "K172017", "K872353", "K161277", "K991219", "K181971", "K190312", "K171603", "K232920", "K983498", "K960148", "K022447", "K914280", "K243830", "K190603", "K883561", "K040760", "K013921", "K920695", "K930731", "K021140", "K840059", "K180557", "K170422", "K852389", "K851870", "K875038", "K161236", "K873557", "K861478", "K871667", "K832915", "K864225", "K250824", "K981489", "K860267", "K854862", "K860055", "K021602", "K850176", "K882157", "K180053", "K903345", "K864669", "K191609", "K060673", "K212868", "K781641", "K160891", "K834401", "K823487", "K180469", "K933941", "K213186", "K881744", "K800109", "K912060", "K992391", "K163068", "K981591", "K180216", "K201436", "K011264", "K170362", "K831446", "K880660", "K190659", "K063742", "K180029", "K974541", "K251469", "K031292", "K172289", "K961446", "K871291", "K162104" ], "device_name": "Stent, Ureteral", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.4620", "device_class": "2", "registration_number": [ "1828132", "3012536737", "3002807314", "1220477", "3010155661", "3011050570", "3009763019", "1225687", "9617744", "2126666", "3033848208", "3009526575", "1646831", "3005987240", "1000121056", "3014246639", "9681442", "9611590", "3010273872", "9610711", "2124215", "3004859241", "1037955", "1313046", "3033589330", "9681477", "1048735", "1000393132", "3005941719", "3011642792", "2027111", "3005580113", "3013460719", "1018233", "9681260", "2030624", "3003790304", "3007156625", "2125050", "2527072", "3005099803", "3016678045", "3012050423", "3010131137", "1647149", "2183744", "3021632375", "3007695959", "3012649202", "2246552", "3015225571", "1721504", "3013023255", "3003814961", "3024807849", "3004365956", "3030087693", "3006082230", "3016096097", "3015309643", "1123137", "3005232773", "1424778", "3006950086", "3001845648", "3009051888", "3003915875", "1820334", "3017210488", "3008797804", "1825146" ], "fei_number": [ "1828132", "3012536737", "3002806368", "3002807314", "1000306139", "3002807917", "1220477", "3010155661", "3011050570", "3009763019", "2126666", "3006279007", "3033848208", "3009526575", "1000160215", "1721504", "3005987240", "1000121056", "3014246639", "3002807439", "1000123180", "3010273872", "2124215", "3004859241", "1037955", "1313046", "3033589330", "1048735", "1000393132", "3011642792", "2027111", "3005580113", "3013460719", "1018233", "3003473227", "3003790304", "2125050", "2527072", "3005099803", "3002807111", "3012050423", "3010131137", "3016678045", "2183744", "3021632375", "3007695959", "3012649202", "2246552", "3002806565", "3015225571", "3013023255", "1000237915", "3024807849", "3004365956", "3030087693", "3006082230", "3016096097", "3015309643", "3003814961", "3005232773", "3006950086", "3001845648", "3009051888", "3003915875", "1820334", "3017210488", "3008133910", "3000206435", "3001451463", "3008797804", "1825146" ] } } ] }