{ "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": 1 } }, "results": [ { "cfres_id": "30057", "product_res_number": "Z-0237-04", "event_date_initiated": "2003-10-24", "event_date_posted": "2003-12-18", "recall_status": "Terminated", "event_date_terminated": "2005-02-09", "res_event_number": "27465", "product_code": "FRC", "product_description": "3M Attest 1264P Biological Indicators, in boxes of 25 per box", "code_info": "Lot numbers 2005-07 DW, 2005-08 DD, and 2005-08 DL", "firm_fei_number": "2110898", "recalling_firm": "3m Health Care", "address_1": "3m Center", "city": "Saint Paul", "state": "MN", "postal_code": "55144-1001", "additional_info_contact": "Cynthia Lamarucciola\n651-733-7605", "reason_for_recall": "The 3M Attest 1264/1264P Biological Indicators of ETO sterilization contain a microbiological contaminant which can affect the performance of the positive control and the indicators to some limited extent. The color on a positive control may revert to negative after 24 hours of incubation.", "root_cause_description": "Other", "action": "The firm conducted a field correction which began on 10/24/03. They provided revised labeling for the product. Letters, dated October 24, 2003, were sent to consignees. The letters had a description of the problem, instructions for doing the relabeling in the field, and recommendations for users of the product.", "product_quantity": "1844 boxes of 25 biological indicators per box", "distribution_pattern": "The product was distributed nationwide in the United States and worldwide.", "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" } } ] }