{ "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": "67890", "product_res_number": "Z-0804-2008", "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\" 3.00 x 15 Dilatation Catheter, Catalog # 80115300, Distributed by Cordis Corporation, Miami Lakes, FL 33014", "code_info": "Lot #s: 13187446 13191355 13197622 13200865 13214556 13221415 13223385 13225878 13231289 13236340 13239277 13247916 13261565 13264549 13268859 13279605 13280401 13280405 13281186 13281219 13281279 13281314 13281364 13281432 13281451 13282065 13284571 13287298 13292703 13293584 13295107 13304559 13306306 13309113 13314818 13315461 13317743 and 13321813", "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": [ "K896108", "K123264", "K252116", "K110133", "K153742", "K150292", "K212393", "K133633", "K820410", "K251970", "K861847", "K162209", "K123279", "K163174", "K220634", "K180040", "K242969", "K121196", "K180921", "K110617", "K261428", "K103095", "K153682", "K163114", "K141236", "K261759", "K121222", "K203390", "K121667", "K152485", "K220629", "K122178", "K211807", "K211393", "K141025", "K230374", "K141090", "K160823", "K160961", "K143480", "K141933", "K143160", "K130391", "K131450", "K113775", "K182699", "K233729", "K162625", "K181023", "K223189", "K160985", "K211349", "K134031", "K210012", "K111544", "K131169", "K223022", "K173581", "K843944", "K163200", "K103808", "K103153", "K112735", "K103110", "K163372", "K172264", "K133852", "K111284", "K202619", "K163660", "K123473", "K200269", "K170941", "K254022", "K162434", "K222538", "K192344", "K113464", "K230705", "K233499", "K121681", "K173680", "K233505", "K113220", "K202578", "K252295", "K103657", "K110134" ], "pma_number": [ "P990008", "P860019", "P880003", "P930012", "P870021", "P970052", "P790017", "P880027", "P950020", "P850021", "P890048", "P960014", "P910031", "P890032", "P940009", "P840040", "P880065", "P870036", "P810046", "P020037", "P880055", "P890001" ], "registration_number": [ "", "3010432890", "3011564431", "3015453963", "3009018440", "3002807315", "3004824117", "2124215", "3013152301", "3009965866", "8010026", "3006946276", "3014222368", "3016678045", "3006550224", "3008700817", "3013341368", "3002807314", "8043892", "3018805824", "2011171", "2134812", "1000121056", "1225687", "1721686", "3013546453", "3008824097", "3007156625", "3003898360", "3012693555", "3014461810", "3004091615", "3012050423", "3015002281", "3030421123", "3031550970", "2134265", "3004415014", "3003775186", "3008573567", "3030236028", "3013634084", "3014656749", "3008002401", "3017961114", "1313046", "1422634", "9617601", "3007836437", "2024168", "3010131137", "9681834", "3009205152", "3012167431", "9612164", "3044156918", "3024893679", "9614654", "3014390222", "3019807891", "3003084171", "3009564766", "3015910259", "3010220595", "3043534762", "2183744", "1319639", "1028232", "2939561", "3010273872", "9681260", "3006513822", "3013944123", "3011137372", "3009613036", "3017262662", "3035111606", "3010391265", "9710284", "3034695832" ], "fei_number": [ "", "3010432890", "3011564431", "3015453963", "1000138054", "3005747797", "3009018440", "3002807315", "3004824117", "3002808050", "3001451463", "2124215", "3013152301", "2828", "3009965866", "3002827704", "1000514656", "3006946276", "3002808904", "3002808327", "3014222368", "3002806434", "3016678045", "3006550224", "3008700817", "3013341368", "3002807314", "3018805824", "2011171", "1000121056", "1721686", "3013546453", "3008824097", "3003898360", "3012693555", "3002806565", "3014461810", "3004091615", "3012050423", "3015002281", "3030421123", "3031550970", "3004635528", "3004415014", "3003775186", "3008573567", "3008133910", "3030236028", "3013634084", "3014656749", "3008002401", "3017961114", "1313046", "3002095335", "3002534070", "3007836437", "2024168", "3010131137", "3009205152", "3012167431", "3044156918", "3024893679", "3014390222", "3019807891", "3003084171", "3009564766", "3003182398", "3015910259", "3010220595", "3043534762", "2183744", "1028232", "3010273872", "3006513822", "3013944123", "3009613036", "3017262662", "3035111606", "3010391265", "3034695832" ], "device_name": "Catheters, Transluminal Coronary Angioplasty, Percutaneous", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.5100", "device_class": "2" } } ] }