{ "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": "67871", "product_res_number": "Z-0787-2008", "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\" 1.50 x 10, Dual Maker Band, Dilatation Catheter, Catalog # 8011015D, Distributed by Cordis Corporation, Miami Lakes, FL 33014", "code_info": "Lot #s: 13200863 13221408 13224938 13235880 13264547 13271983 13280404 13281196 13281257 13281376 13281426 13288054 13291130 13305475 13307824 13311784 13316297 and 13321689", "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" } } ] }