{ "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": "38155", "product_res_number": "Z-0205-06", "event_date_initiated": "2005-03-18", "event_date_posted": "2005-11-29", "recall_status": "Terminated", "event_date_terminated": "2012-04-12", "res_event_number": "31560", "product_code": "FRC", "k_numbers": [ "K994381" ], "product_description": "Self Contained Biological Indicator, product code SCRE-06, lots 643 and 674.", "code_info": "lot codes 643, exp. date 4/05 and lot 674, exp. 10/05.", "firm_fei_number": "1521876", "recalling_firm": "Namsa", "address_1": "6750 Wales Rd", "city": "Northwood", "state": "OH", "postal_code": "43619-1012", "additional_info_contact": "Matthew Sliva\n419-666-9455 Ext. 331", "reason_for_recall": "The certified Ethylene Oxide D-values of the lots cannot be confirmed to be within specification.", "root_cause_description": "Other", "action": "The firm contacted consignees by phone on or about 3/18/05 and sent a follow up letter on or about 3/31/05. Consignees are asked to contact their customers if they further distributed the product.", "product_quantity": "lot 643: 10/50 kit boxes; lot 674: 39 boxes.", "distribution_pattern": "Domestic accounts: SRI International, 333 Ravenswood, Menlo Park, CA 94025; NAMSA, 6750 Wales, Northwood, OH 43619; Smiths Medical ASD, Inc., 10 Bauman Drive, Keene, NH 03431; Medisystems, 701 Pike St., Seattle, WA 98101; Inverness, 17-10 Willow St., Fairlawn, NJ 07410; \n\nInternational Accounts: Sterisure Associates, Shop No-2 Parachawl, Jijama, Pump House Mumbai India; \nBiomedical Research and Support Services (BRASS), 59 Ubi Ave., #06-04 Bizlink Center, Singapore 65 67426007", "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" } } ] }