{ "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": "66458", "product_res_number": "Z-0713-2008", "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 Cannula for Laparoscopy\nPart Numbers: ASP 105, ASP 150, ASP 145, ASP 180, Coloplast Corp., Minneapolis, MN 55411", "code_info": "All un-expired lots are being recalled.   ASP 105 ASP 145: Lot Serial # 7030294 ASP14502001 ASP14504101517  ASP14504023142 ASP1455022514 ASP1454110199 ASP14503019 ASP14502001 ASP14503019 ASP14503017 ASP14503019 ASP14503017 ASP14502001 ASP14503017 ASP14502001 ASP14504023142 ASP14504101517 ASP14504023142 ASP14504101517 ASP14504110200 ASP1455022514 ASP1454110199 ASP1455031783 ASP1454110199 ASP1455031783 ASP1455041217 ASP1454110199 ASP1455041217 ASP1455052183 ASP1455041217 ASP1455033506 ASP1455041217 ASP1455052183 ASP1455041217 ASP1454110199 ASP1455041217 ASP1455052183 ASP1454110199 ASP1455052183 ASP 150: Lot serial # ASP15002001 ASP 180: Lot Serial #7044270 7044267 04041932", "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": "154", "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" } } ] }