{ "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": "67873", "product_res_number": "Z-0789-2008", "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\" 2.00 x 10, Dual Marker Band, Dilatation Catheter, Catalog # 8011020D, Distributed by Cordis Corporation, Miami Lakes, FL 33014", "code_info": "Lot #s: 13188605 13192861 13195491 13205387 13212421 13214548 13222778 13224932 13227002 13230714 13232858 13237698 13237904 13245573 13258620 13260780 13267186 13281342 13281424 13282061 13290334 13291893 13293578 13293670 13295101 13304555 13305488 13309108 13313284 13319350 and 13321696", "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" } } ] }