{ "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": "67353", "product_res_number": "Z-0757-2008", "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 \"Dura Star\" 2.75 x 15 Dilatation Catheter, Catalog # 70115275, Distributed by Cordis Corporation, Miami Lakes, FL 33014", "code_info": "Lot #s: 13185357 13195488 13195989 13209916 13216630 13245568 13267867 13274854 13275169 13279924 13285517 13291124 13291889 13310113 and 13313279", "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" } } ] }