{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "44452", "product_res_number": "Z-0674-06", "event_date_initiated": "2006-03-01", "event_date_posted": "2006-03-23", "recall_status": "Terminated", "event_date_terminated": "2008-07-01", "res_event_number": "34671", "product_code": "FAD", "product_description": "Cook Harrison fetal bladder stent set, sterile; REF J-HFBS-503540.", "code_info": "All units.", "firm_fei_number": "1825146", "recalling_firm": "Cook Urological, Inc.", "address_1": "1100 W Morgan St", "city": "Spencer", "state": "IN", "postal_code": "47460-9426", "additional_info_contact": "Julie Ross\n812-829-4891", "reason_for_recall": "Instructions for Use (IFU) booklet missing pages 5-12. Pages 5-8 in English; 9-12 in Danish, describe stent duration, patient preparation, assembly, implanting, follow-up and removal instructions. IFU, device description, indications, contraindications, warnings, precautions, patient counseling, clinical usage, clinical study data, adverse events. One patient booklet lacked pages 3-6, & 55-58.", "root_cause_description": "Other", "action": "Consignees were notified via letter dated 3/1/06 that included one copy of the instructions. Consignees were asked to inform the firm of how many additional copies were needed for stocks on hand and instructed to make copies as needed until additional supplies are received.", "product_quantity": "1300", "distribution_pattern": "Nationwide, Australia, Canada, Caracas, Chile, Colombia, Hong Kong, India, Ireland, Israel, Malaysia, Mexico, New Zealand, Paraguay, Taiwan and Venezuela.", "openfda": { "k_number": [ "K871667", "K151051", "K861478", "K013784", "K040760", "K904231", "K860055", "K072293", "K981491", "K021140", "K021602", "K823487", "K862539", "K930731", "K180053", "K910691", "K232920", "K800109", "K161277", "K251469", "K213444", "K211934", "K163068", "K163399", "K160891", "K190603", "K863492", "K832915", "K872353", "K850175", "K030503", "K961371", "K831446", "K920695", "K060673", "K873557", "K213185", "K923394", "K013921", "K820870", "K830884", "K834401", "K180216", "K170362", "K191609", "K992391", "K250824", "K251890", "K905505", "K781641", "K243830", "K180557", "K914280", "K961446", "K941952", "K082805", "K190312", "K960148", "K173734", "K852389", "K243039", "K043193", "K190659", "K180057", "K864669", "K200260", "K983498", "K981489", "K022447", "K913928", "K850176", "K912060", "K930733", "K180469", "K172017", "K833782", "K881744", "K162104", "K854862", "K063742", "K191446", "K860267", "K973504", "K903345", "K840059", "K011264", "K882157", "K031292", "K213186", "K033210", "K946296", "K170010", "K991219", "K010002", "K172289", "K212868", "K141344", "K864225", "K162109", "K865085", "K875038", "K930882", "K981591", "K831857", "K871291", "K894357", "K161236", "K170422", "K952513", "K982974", "K180029", "K854908", "K925282", "K171603", "K905289", "K851870", "K201436", "K883561", "K181971", "K880660", "K933941", "K974541" ], "device_name": "Stent, Ureteral", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.4620", "device_class": "2", "registration_number": [ "1037955", "3016096097", "3012536737", "3024807849", "9610711", "1424778", "3015309643", "9681477", "3003915875", "3005987240", "9681260", "3017210488", "1820334", "3012649202", "3011642792", "1828132", "1220477", "3010131137", "1000121056", "3009526575", "3007156625", "1123137", "3009051888", "3014246639", "3033848208", "9611590", "3005099803", "3007695959", "3033589330", "1313046", "3004859241", "3003814961", "3005232773", "3030087693", "1646831", "1048735", "2030624", "3016678045", "9681442", "3015225571", "1721504", "1000393132", "3006082230", "2183744", "3010273872", "2527072", "3010155661", "1647149", "3008797804", "2126666", "3002807314", "3012050423", "1825146", "9617744", "2027111", "3013023255", "3001845648", "1225687", "1018233", "3005941719", "3006950086", "3021632375", "3004365956", "2125050", "3011050570", "3009763019", "3013460719", "2246552", "3003790304", "3005580113", "2124215" ], "fei_number": [ "1037955", "3016096097", "3002807439", "3012536737", "3024807849", "3015309643", "3005987240", "3003915875", "3017210488", "1820334", "3012649202", "3011642792", "1828132", "1220477", "3010131137", "1000121056", "3009526575", "3014246639", "3009051888", "3033848208", "3008133910", "3005099803", "3007695959", "3033589330", "1313046", "3004859241", "3003814961", "3005232773", "3030087693", "1000160215", "3003473227", "3006279007", "1048735", "3000206435", "1000237915", "3016678045", "3015225571", "1721504", "1000393132", "3006082230", "2183744", "3010273872", "2527072", "3010155661", "3001451463", "3002807111", "3008797804", "3002807314", "3012050423", "2126666", "1825146", "3002807917", "2027111", "3013023255", "3002806565", "3001845648", "1018233", "3002806368", "3006950086", "3021632375", "3004365956", "2125050", "3011050570", "3009763019", "1000123180", "3013460719", "2246552", "3003790304", "3005580113", "1000306139", "2124215" ] } } ] }