{ "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": "67903", "product_res_number": "Z-0816-2008", "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\" 3.50 x 20 Dilatation Catheter, Catalog # 80120350, Distributed by Cordis Corporation, Miami Lakes, FL 33014", "code_info": "Lot #s: 13221105 13221107 13274544 13281200 13281237 13281285 13281306 13281425 13281449 13282486 13283213 13286194 13287301 13303767 13307102 13308631 13312724 13320196 and 13325102", "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": "133,300 units total for recalls Z-0747-0824-2008", "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" } } ] }