{ "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": "66572", "product_res_number": "Z-0715-2008", "event_date_initiated": "2007-11-12", "event_date_posted": "2008-04-03", "recall_status": "Terminated", "event_date_terminated": "2008-11-04", "res_event_number": "45907", "product_code": "FQH", "product_description": "Coloplast Elefant Suction/Irrigation Tubing, Part Number: AST 307, Coloplast Corp., Minneapolis, MN 55411", "code_info": "All un-expired lots are being recalled.   AST 307: Lot Serial# AST30702104", "firm_fei_number": "2125050", "recalling_firm": "Coloplast Corp", "address_1": "1525 W River Rd", "city": "Minneapolis", "state": "MN", "postal_code": "55411-3430", "additional_info_contact": "612-287-4178", "reason_for_recall": "Lack of sterilization assurance: Sterilization of Elefant Suction-Irrigation Devices is not performed according to ISO 11135 standard.", "root_cause_description": "Process design", "action": "Coloplast sent customers an \"Urgent: Recall Notification\" letter on 11/12/07. The letter described that the sterilization of the products was not performed according to ISO 11135 standard. The notification requested the customers to return the product immediately and to send a fax or contact the company via email in regard to inventory at hand. A phone script for distributors also included an advice to discontinue dispensing the product and to fax or email in regard to inventory at hand.", "product_quantity": "4", "distribution_pattern": "Nationwide, including Puerto Rico.", "openfda": { "k_number": [ "K253996", "K874504", "K202071", "K933742", "K820661", "K973485", "K082858", "K221504", "K210987", "K991383", "K011612", "K080779", "K143115", "K810185", "K913568", "K213616", "K253445", "K202222", "K854543", "K922083", "K926337", "K072404", "K974568", "K830386", "K790811", "K874022", "K873466", "K192349", "K060782", "K813607", "K813475", "K222804", "K972069", "K220759", "K022613", "K231023", "K090848", "K033590", "K220964", "K942886", "K854737", "K111313", "K012464", "K113312", "K161165", "K021813", "K972551", "K973803", "K210536", "K951666", "K983135", "K110958", "K970916" ], "registration_number": [ "1020279", "3007829657", "3005173255", "1060680", "3004837686", "3032611331", "3005099803", "1058584", "3002807315", "3043604863", "2029275", "3009217531", "1423507", "3012497308", "1423662", "3007502289", "3010667677", "3038472982", "3003955307", "3015542154", "3008114965", "2027148", "3003587189", "3016678045", "3014351477", "3013440400", "2648623", "8043750", "2242352", "3017540705", "3012649202", "3043622938", "3007225330", "9610711", "2649614", "3008788129", "3013530403", "1526711", "1643264", "3006611221", "2011171", "1000121056", "2648920", "3006535925", "3010872518", "1649139", "3007156625", "3025376090", "3009762450", "1647149", "1057196", "3005083075", "9616684", "3004365956", "1319660", "3008812251", "2184009", "1649518", "3014620201", "3012964172", "9610614", "3007594734", "1018470", "3010041511", "1724474", "2435119", "3005706359", "3010361494", "3014258951", "3004380247", "3005941719", "3012130008", "3030733800", "3002808022", "3010701807", "1526534", "1054811", "3010531069", "3012494290", "3012797688", "3038503932", "1422634", "3042172872", "3007997036", "3002907620", "3007177643", "3011683674", "3010400865", "1043214", "3022320321", "3045076544", "1721676", "9614209", "3010305275", "3004464325", "3009125070", "2020601", "3010034780", "9617155", "1424263", "2025102", "3015173212", "3013557562", "3014118821", "3021784063", "3031571797", "3007366790", "2245304", "2183613", "1417519", "8043484", "1055236", "3007125392", "1420032", "3037027197", "1718850", "3012535730", "3020745223", "1526350", "9617429", "1036836", "2648666", "3010536692", "9615063", "2244478", "3003477135", "8044091", "1043729", "3035366890", "3004932373", "3010273872", "3015967359", "3030535035", "1054241", "3003903031", "9681260", "3011137372", "1526439", "3017252917", "2320762", "2528981", "3002807310", "1417411", "3003814961" ], "fei_number": [ "1020279", "1000116158", "3007829657", "3005173255", "1000219637", "3005747797", "3004837686", "3032611331", "3005099803", "3002807315", "3043604863", "3009217531", "1000208624", "3012497308", "3003040625", "3002808293", "3007502289", "3010667677", "1000514656", "3002807634", "3038472982", "3003955307", "3015542154", "3008114965", "3002406063", "2027148", "3003587189", "3016678045", "3014351477", "3013440400", "2648623", "2242352", "3017540705", "3012649202", "3043622938", "3007225330", "2649614", "3008788129", "3002807111", "3013530403", "1526711", "3007282753", "1643264", "2011171", "1000121056", "3001236277", "3006535925", "3002806920", "3010872518", "3004857377", "3025376090", "3009762450", "1000306431", "3005083075", "1000136269", "3004365956", "3002806565", "3014620201", "3012964172", "3007594734", "1018470", "3010041511", "2435119", "3005706359", "3010361494", "1000136478", "3014258951", "3008133910", "3004380247", "3012130008", "3030733800", "3002808022", "3010701807", "3008002452", "1526534", "3004949275", "3010531069", "3012494290", "3012797688", "3038503932", "3042172872", "1000114185", "3007997036", "3002907620", "3007177643", "3011683674", "3010400865", "1043214", "3022320321", "3002913962", "1000112968", "3045076544", "1721676", "3010305275", "3004464325", "3009125070", "2020601", "3010034780", "1000345108", "3002807584", "3000215273", "3002808194", "3015173212", "3002807917", "3013557562", "1000132037", "3014118821", "3021784063", "3031571797", "3003821398", "2245304", "2183613", "1417519", "3002948288", "3007125392", "1420032", "3037027197", "1000112877", "1718850", "3012535730", "3020745223", "1526350", "1036836", "2648666", "3010536692", "3003477135", "3003094851", "3003015552", "1000306139", "1043729", "3035366890", "3004932373", "3010273872", "3015967359", "1000140478", "3030535035", "3002806725", "3003903031", "1526439", "3017252917", "2528981", "3002807310", "1417411", "3003814961" ], "device_name": "Lavage, Jet", "medical_specialty_description": "General Hospital", "regulation_number": "880.5475", "device_class": "2" } } ] }