{ "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": "67899", "product_res_number": "Z-0812-2008", "event_date_initiated": "2008-01-14", "event_date_posted": "2008-02-06", "recall_status": "Terminated", "event_date_terminated": "2009-10-20", "res_event_number": "46378", "product_code": "LOX", "pma_numbers": [ "P880003" ], "product_description": "CORDIS \"Fire Star\" 2.50 x 20 Dilatation Catheter, Catalog # 80120250, Distributed by Cordis Corporation, Miami Lakes, FL 33014", "code_info": "Lot #s: 13187448 13191357 13197625 13197626 13203922 13203923 13212424 13212425 13224187 13224189 13225882 13231288 13232326 13233516 13236343 13237912 13242129 13246360 13247918 13252929 13253835 13270369 13279283 13280403 13281233 13281287 13281301 13281328 13281330 13281333 13281392 13281399 13281427 13282483 13283210 13285523 13288830 13290337 13292699 13294554 13297302 13302302 13306834 13311785 13313289 13314187 13315462 13316298 13317745 13321822 13325807 13325808", "firm_fei_number": "1016427", "recalling_firm": "Cordis Corporation", "address_1": "14201 NW 60th Avenue", "city": "Miami Lakes", "state": "FL", "postal_code": "33014-2802", "additional_info_contact": "786-313-2000", "reason_for_recall": "Slow Deflation or No Deflation", "root_cause_description": "Process control", "action": "Cordis initated the recall on 1/14/2008. For U.S. customers: An Urgent Medical Device Recall letter and an Acknowledgement Form was sent to the following 4 individuals in each account: Cath Lab Director, Operating Room Director, Materials Director, Risk Manager; to be followed up with direct Cordis representative contact to facilitate obtaining signature, faxing form, collecting and returning units. For non-US customers, email notification with return acknowledgement is used to notify the affiliate distributors, who then notify and reconcile the customers in those countries. All users were instructed to immediately set aside product and return it for replacement.", "product_quantity": "52 Ea", "distribution_pattern": "Worldwide.", "openfda": { "k_number": [ "K162434", "K180921", "K123279", "K202619", "K133852", "K233505", "K111284", "K222538", "K233729", "K150292", "K223189", "K123264", "K103808", "K181023", "K210012", "K252116", "K163114", "K212393", "K173581", "K110617", "K242969", "K182699", "K113775", "K121667", "K134031", "K843944", "K110134", "K261759", "K233499", "K113220", "K223022", "K211349", "K180040", "K820410", "K131169", "K153682", "K170941", "K152485", "K163174", "K141236", "K112735", "K121222", "K143480", "K162625", "K896108", "K103153", "K131450", "K160985", "K254022", "K143160", "K160961", "K103657", "K163660", "K122178", "K220634", "K130391", "K103110", "K200269", "K861847", "K113464", "K141933", "K123473", "K160823", "K103095", "K121681", "K141090", "K230374", "K211393", "K141025", "K211807", "K202578", "K162209", "K163372", "K121196", "K251970", "K203390", "K252295", "K133633", "K172264", "K173680", "K192344", "K220629", "K163200", "K261428", "K111544", "K153742", "K230705", "K110133" ], "pma_number": [ "P840040", "P930012", "P880003", "P880065", "P790017", "P940009", "P890032", "P020037", "P890048", "P970052", "P910031", "P870036", "P880027", "P990008", "P880055", "P810046", "P850021", "P890001", "P960014", "P860019", "P950020", "P870021" ], "registration_number": [ "", "3006513822", "3014461810", "3009018440", "3003084171", "3034695832", "1000121056", "3011564431", "3004091615", "9612164", "1313046", "3006550224", "2134812", "3016678045", "3013944123", "3024893679", "3012050423", "3010391265", "3030421123", "3008573567", "3013546453", "3013341368", "2011171", "3044156918", "9614654", "3031550970", "9681834", "2939561", "2024168", "3006946276", "3009613036", "3015453963", "3014390222", "3035111606", "3030236028", "2134265", "3010220595", "1225687", "3003775186", "3018805824", "9710284", "3019807891", "1721686", "9681260", "3007156625", "1028232", "3013634084", "3012693555", "3004824117", "3004415014", "3014656749", "3011137372", "8043892", "3009205152", "3012167431", "3008002401", "3015910259", "3002807314", "1319639", "3008824097", "3010432890", "3007836437", "1422634", "8010026", "2124215", "9617601", "3003898360", "3017262662", "3002807315", "3015002281", "3010131137", "3014222368", "3017961114", "3009564766", "2183744", "3010273872", "3009965866", "3043534762", "3008700817", "3013152301" ], "fei_number": [ "", "3006513822", "3014461810", "3009018440", "3003084171", "3034695832", "1000121056", "3011564431", "3004091615", "1313046", "3006550224", "3016678045", "3013944123", "3024893679", "3001451463", "3012050423", "3010391265", "3030421123", "3008573567", "3013546453", "3013341368", "2011171", "3004635528", "3044156918", "3031550970", "1000138054", "3008133910", "3002095335", "2024168", "3006946276", "3009613036", "3015453963", "3014390222", "3035111606", "3002534070", "3030236028", "3010220595", "3003775186", "3002827704", "3018805824", "1000514656", "3019807891", "1721686", "1028232", "3013634084", "3012693555", "3004824117", "3004415014", "3014656749", "3009205152", "3002808327", "3012167431", "3008002401", "3015910259", "3002807314", "3008824097", "3002806565", "3010432890", "3007836437", "2124215", "3003898360", "3002808050", "3017262662", "2828", "3002807315", "3015002281", "3010131137", "3014222368", "3017961114", "3002808904", "3009564766", "2183744", "3010273872", "3002806434", "3005747797", "3009965866", "3043534762", "3008700817", "3013152301", "3003182398" ], "device_name": "Catheters, Transluminal Coronary Angioplasty, Percutaneous", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.5100", "device_class": "2" } } ] }