{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 40 } }, "results": [ { "cfres_id": "83495", "product_res_number": "Z-0066-2010", "event_date_initiated": "2009-06-23", "event_date_posted": "2009-10-20", "recall_status": "Terminated", "event_date_terminated": "2011-11-29", "res_event_number": "52632", "product_code": "FRC", "k_numbers": [ "K031226", "K994055" ], "product_description": "Sterrad CycleSure Biological Indicator, Product Code 14324.\n\nThe Sterrad CycleSure Biological Indicator is intended to be used as a standard method for frequent monitoring of the Sterrad Sterilizer cycles.", "code_info": "All Lots.", "firm_fei_number": "3003662624", "recalling_firm": "Advanced Sterilization Products", "address_1": "33 Technology Drive", "city": "Irvine", "state": "CA", "postal_code": "92618", "additional_info_contact": "949-453-6410", "reason_for_recall": "Biological Indicator indicating a positive result does not maintain yellow color for the entire incubation period and some indicators experience media evaporation prior to the end of the labeled maximum incubation time.", "root_cause_description": "Device Design", "action": "An Important Product Labeling Correction - New Instructions for Use dated, June 26, 2009, has been proposed to be sent by the firm for Cyclosure Biological Indicators to consignees. The revised instructions reduce the maximum read time for the indicators to 3 days (72 hours). The letter also states why ASP changed the Instructions. Questions are to be directed to ASP Customer Care Center.", "distribution_pattern": "Worldwide Distribution.", "openfda": { "k_number": [ "K200996", "K173437", "K111515", "K173634", "K122024", "K172752", "K241959", "K160546", "K993775", "K140620", "K182931", "K252680", "K170427", "K093794", "K792649", "K090514", "K133549", "K822024", "K141244", "K163646", "K890754", "K800029", "K925496", "K121593", "K810930", "K200970", "K052128", "K023716", "K231383", "K140499", "K073618", "K070595", "K020026", "K854902", "K981497", "K241542", "K991618", "K963841", "K112018", "K770953", "K220473", "K172432", "K240717", "K173629", "K930683", "K832922", "K841709", "K910417", "K192550", "K092906", "K991675", "K113221", "K850144", "K172474", "K221641", "K173435", "K792648", "K004009", "K042450", "K123017", "K141238", "K171003", "K962441", "K171504", "K113302", "K212193", "K251452", "K210277", "K183300", "K233814", "K972747", "K241710", "K151482", "K994055", "K151971", "K091950", "K140589", "K223023", "K050591", "K900771", "K193154", "K032723", "K971430", "K852192", "K961721", "K844479", "K971432", "K022706", "K092944", "K855120", "K242453", "K872867", "K051643", "K173584", "K771132", "K092755", "K171287", "K841583", "K103277", "K213296", "K884615", "K200536", "K050664", "K926364", "K243501", "K802228", "K171587", "K912796", "K051056", "K103321", "K903024", "K921909", "K923739", "K141312", "K260766", "K041386", "K103222", "K211705", "K801678", "K122044", "K182404", "K812272", "K191021", "K223717", "K102884", "K133267", "K020205", "K183294", "K242538", "K192001", "K173633", "K250044", "K960790", "K163144", "K202879", "K032914", "K031012", "K231490", "K122362", "K071014", "K152060", "K111391", "K181686", "K994381", "K894399", "K895704", "K925745", "K854631", "K181434", "K233681", "K761015", "K203560", "K101910", "K894398", "K771080", "K863122", "K250061", "K800482", "K140708", "K173670", "K121484", "K140392", "K192980", "K123546", "K051173", "K133322", "K891366", "K884767", "K111375", "K181429", "K111150", "K041099", "K855101", "K200092", "K172748", "K170070", "K891784", "K902344", "K192025", "K905425", "K202721", "K960777", "K090569", "K200126", "K922212", "K041784", "K930682", "K170039", "K173488", "K173626", "K130263", "K082756", "K151585", "K213881", "K073244", "K200766", "K031226", "K141580", "K190297", "K024079", "K083665", "K251122", "K071537", "K213809", "K173519", "K223715" ], "registration_number": [ "3004634710", "3012421607", "3031757047", "2084725", "3030733800", "3036504234", "3012494290", "3007412809", "3015392401", "2028456", "3013667284", "3014579161", "3013145340", "3009968482", "1720309", "2410251", "3043226252", "2432141", "2133641", "3014421917", "3009609218", "1416605", "3013298431", "3011061109", "3016678045", "8030087", "1319130", "3038718579", "3013557562", "3042272797", "2029076", "3012723641", "3030626857", "2183301", "3031841433", "3000251274", "9611959", "2434982", "3003476474", "3004080920", "3016075971", "3017524825" ], "fei_number": [ "3004634710", "3012421607", "3031757047", "1000125215", "3030733800", "3036504234", "3012494290", "3007412809", "3015392401", "3013667284", "3014579161", "3013145340", "3009968482", "3014534", "1720309", "2410251", "3043226252", "2432141", "3003662624", "1000160630", "3014421917", "3009609218", "1416605", "3002677549", "3013298431", "3011061109", "3016678045", "1319130", "3038718579", "3013557562", "3042272797", "3030626857", "2183301", "3031841433", "3000251274", "3000203466", "2434982", "3003476474", "3004080920", "3016075971", "3017524825", "3005343391" ], "device_name": "Indicator, Biological Sterilization Process", "medical_specialty_description": "General Hospital", "regulation_number": "880.2800", "device_class": "2" } } ] }