{ "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": 32 } }, "results": [ { "cfres_id": "176860", "product_res_number": "Z-0250-2020", "event_date_initiated": "2019-10-04", "event_date_created": "2019-10-30", "recall_status": "Terminated", "event_date_terminated": "2020-12-14", "res_event_number": "83977", "product_code": "LIT", "k_numbers": [ "K991811" ], "product_description": "Cordis MAXI LD PTA Dilatation Catheter, for cardiovascular use.", "code_info": "Catalog Number: 4171460S; Lot Number: 82169860; Expiry Date: 10/31/2020", "firm_fei_number": "1016427", "recalling_firm": "Cordis Corporation", "address_1": "14201 NW 60th Ave", "city": "Miami Lakes", "state": "FL", "postal_code": "33014-2802", "additional_info_contact": "786-313-2000", "reason_for_recall": "Product was manufactured utilizing an expired inner body.", "root_cause_description": "Process control", "action": "Cordis notified customers on about 10/04/2019, via Urgent MEDICAL DEVICE RECALL letter delivered by sales representatives. Customers were informed that the Cordis MAXI LD\" PTA Dilatation Catheter was manufactured utilizing an expired inner body. For an expired inner body, a degradation of material may contribute to a collapse of the guidewire lumen resulting in a resistance during insertion or backloading of the guidewire into the lumen. \n\nInstructions included to read the recall letter, immediately check inventory to conform if the affected product is in your possession, identify and set aside any units from the affected lot, complete and return the provided Acknowledgement Form directly to Cordis via fax (614-495-5571) or email to GMB-FieldCorrectiveAction@cardinalhealth.com. Customers were also instructed to arrange for return of affected product, provide the recall letter to personnel at your facility who need to be made aware and any other facility that may have been sent the affected units.", "product_quantity": "21 units", "distribution_pattern": "US distribution to AL, AZ, FL, MN, and MO", "openfda": { "k_number": [ "K882925", "K940063", "K080925", "K880298", "K910996", "K152080", "K894899", "K915895", "K142654", "K973563", "K102482", "K943298", "K844972", "K921254", "K905250", "K842556", "K133861", "K930745", "K201333", "K942400", "K905698", "K173515", "K163231", "K103354", "K132020", "K945465", "K162350", "K933236", "K071042", "K173894", "K131199", "K854319", "K915347", "K851854", "K940868", "K883346", "K160013", "K911870", "K932537", "K911639", "K935501", "K000570", "K881088", "K981407", "K112697", "K955886", "K882826", "K052757", "K993305", "K843501", "K102705", "K123358", "K051916", "K000798", "K223177", "K901601", "K141521", "K121385", "K833248", "K900677", "K844913", "K102645", "K942635", "K230191", "K170193", "K242419", "K041293", "K181529", "K121265", "K970725", "K920547", "K830733", "K221414", "K222065", "K942293", "K103751", "K230263", "K964881", "K993639", "K923826", "K080982", "K960517", "K122379", "K113681", "K911203", "K052038", "K934793", "K833616", "K945943", "K081417", "K871796", "K944815", "K160004", "K941706", "K934378", "K902091", "K946052", "K130293", "K925945", "K093970", "K072824", "K960501", "K221245", "K073318", "K252512", "K120722", "K051519", "K871011", "K851848", "K933975", "K121442", "K993913", "K003159", "K132430", "K813331", "K914500", "K120971", "K133043", "K903582", "K894944", "K934411", "K850760", "K151317", "K983830", "K152887", "K260304", "K914976", "K884327", "K214038", "K003114", "K120677", "K991540", "K971577", "K063563", "K003972", "K882052", "K093965", "K221057", "K201794", "K874706", "K921577", "K812168", "K911089", "K862550", "K911130", "K902367", "K172494", "K040954", "K120738", "K903417", "K912984", "K030062", "K072798", "K243704", "K970620", "K110319", "K162316", "K843383", "K921856", "K923638", "K142459", "K913391", "K904410", "K001087", "K171251", "K143561", "K963688", "K210626", "K924047", "K965183", "K926271", "K103464", "K141118", "K112513", "K113769", "K071189", "K980390", "K885247", "K951248", "K241740", "K214009", "K131329", "K983055", "K973013", "K830608", "K130786", "K100921", "K021996", "K003276", "K981906", "K120164", "K910965", "K151141", "K111295", "K953298", "K925485", "K180007", "K152873", "K141112", "K884481", "K160941", "K190753", "K151153", "K924276", "K872542", "K870215", "K192318", "K895179", "K142261", "K171290", "K862467", "K881197", "K904984", "K150946", "K901767", "K072947", "K972512", "K092361", "K880158", "K090364", "K201170", "K202800", "K896520", "K921706", "K942154", "K132777", "K220410", "K191275", "K181323", "K133843", "K972357", "K130161", "K931009", "K972800", "K971579", "K073472", "K161427", "K902317", "K093286", "K121175", "K093720", "K893411", "K251915", "K834429", "K103322", "K875064", "K841961", "K897124", "K173621", "K913297", "K120660", "K970466", "K822245", "K150303", "K192399", "K970379", "K001134", "K952064", "K241683", "K231402", "K152240", "K911196", "K080264", "K192907", "K922610", "K953602", "K991977", "K050645", "K190037", "K072765", "K992320", "K897106", "K890800", "K211044", "K202231", "K143041", "K181128", "K241025", "K933183", "K093636", "K890405", "K212215", "K121402", "K896403", "K113468", "K100490", "K051042", "K062843", "K831659", "K991811", "K060960", "K152665", "K942150", "K241040", "K160256", "K250706", "K924320", "K152230", "K023504", "K111899", "K971010", "K834220", "K953608", "K803057", "K905773", "K952063", "K030742", "K912317", "K241711", "K142300", "K880612", "K913689", "K851080", "K143193", "K102035", "K121856", "K101361", "K915349", "K934191", "K093139", "K071309", "K953647", "K141150", "K122070", "K130911", "K843880", "K962945", "K945693", "K992825", "K853746", "K931384", "K953569", "K152934", "K910155", "K903606", "K832474", "K120805", "K143036", "K961980", "K902454", "K201246", "K000101", "K850075", "K933483", "K142954", "K213631", "K950119", "K151678", "K113300", "K092286", "K122984", "K831403", "K201377", "K923947", "K060959", "K971516", "K910822", "K092455", "K140351", "K020854", "K163479", "K921943", "K963000", "K901018", "K944016", "K143652", "K132810", "K915168", "K150452", "K952884", "K101047", "K970299", "K101062", "K221832", "K172033", "K934433", "K221339", "K983650", "K890325", "K130414", "K924358", "K942094", "K910995", "K911215", "K003052", "K972744", "K954313", "K875175", "K151744", "K944989", "K142379", "K900094", "K971448", "K923611", "K170635", "K913112", "K123544", "K200700", "K112797", "K894250", "K880194", "K130397", "K143093" ], "pma_number": [ "P950020" ], "registration_number": [ "", "3010291427", "1646831", "3013391155", "2030598", "1054241", "3003775186", "3002807315", "3012448339", "2939561", "9681260", "3019677404", "3004415014", "9618000", "2528981", "2134626", "3002807090", "3016927279", "3011142981", "1318694", "3012050423", "8043892", "3002807314", "1225687", "1721676", "1282497", "2011171", "9617592", "2124215", "3004091615", "3005994106", "3004730544", "1000393132", "3008361782", "1219930", "1721686", "3008261722", "3007738736", "3022627847", "3011088743", "3016591327", "2183870", "2134265", "3015002281", "3014656749", "3013944123", "3010432890", "1000121056", "3005718570", "3010273872", "1000563940", "1043214", "3014390222", "1643817", "9616666", "3009965866", "3005580113", "3009018440", "2024024", "3015453963", "3015910259", "3010220595", "1647149", "2183744", "9614654", "3006082230", "3006550224", "3027395815", "3010391265", "3030574705", "9617601", "3021140368", "2020394", "1055236", "3014687026", "1220452", "1313046", "3002806603", "3027343398", "9681477", "3011471056", "2024168", "1018233", "3018805824", "3014222368", "3016678045", "1016427", "1319639", "1422634", "3000247873", "3009564766", "3008700817", "1820334", "1028232" ], "fei_number": [ "", "3010291427", "3013391155", "3002807439", "3002468371", "1000518731", "3003007911", "3003775186", "3002807315", "3012448339", "3019677404", "3004415014", "2528981", "3002806565", "3016927279", "3011142981", "1318694", "3012050423", "3004635528", "3002807314", "3002534070", "1000138054", "1721676", "1000160215", "3002095335", "1282497", "2011171", "3008906816", "2124215", "1000514656", "3004091615", "3005994106", "3004730544", "1000393132", "3008361782", "1219930", "1721686", "3008261722", "3007738736", "3022627847", "1000112877", "3011088743", "3016591327", "2183870", "3006003617", "3001451463", "1000306139", "3015002281", "3014656749", "3013944123", "3010432890", "1000121056", "3005718570", "3010273872", "1000563940", "1043214", "3014390222", "1643817", "3009965866", "3009018440", "2024024", "3005580113", "3003245778", "3015453963", "3015910259", "3010220595", "2183744", "3002808904", "3002808050", "3006082230", "3006550224", "3027395815", "3010391265", "3030574705", "3021140368", "2020394", "3014687026", "1220452", "1000112968", "1313046", "3002806603", "3027343398", "3011471056", "2024168", "1018233", "3018805824", "3014222368", "3016678045", "1016427", "3000247873", "3009564766", "3008700817", "1820334", "1028232" ], "device_name": "Catheter, Angioplasty, Peripheral, Transluminal", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.1250", "device_class": "2" } } ] }