{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "145925", "product_res_number": "Z-0086-2017", "event_date_initiated": "2016-04-22", "event_date_created": "2016-10-31", "recall_status": "Terminated", "event_date_terminated": "2018-06-14", "res_event_number": "74018", "product_code": "BSP", "k_numbers": [ "K072005" ], "product_description": "15 g R.K. Epidural Needle (TW), Catalog #/REF #100-1415 \nIntended for the epidural placement, directly or through an epidural catheter, of anesthetic agents to elicit regional anesthesia", "code_info": "1) Spectra Lot# GC091702 (Epimed manufacturing lot # 2801501, Sterile Lot # 12157181) 2) Spectra Lot# GC101871 (Epimed manufacturing lot # 3211503, Sterile Lot # 12157445) 3) Spectra Lot# GC101897 (Epimed manufacturing lot # 3161501, Sterile Lot # 12157325)", "firm_fei_number": "1316297", "recalling_firm": "Epimed International, Inc.", "address_1": "141 Sal Landrio Dr Crossroads Business Park", "city": "Johnstown", "state": "NY", "postal_code": "12095-3835", "additional_info_contact": "Bobbi Harrington\n518-725-0209", "reason_for_recall": "There is a possibility that the needles may have the potential to skive a catheters outer coating. If this were to occur, there exists the risk that a portion of the catheter could remain in the patient, which may require otherwise unnecessary medical invention.", "root_cause_description": "Employee error", "action": "On April 22, 2016, Epimed sent an Urgent Medical Device Recall notices and Recall Return Response Forms to their customers via courier service. Customers were advised to examine all inventory and quarantine product subject to recall immediately. \n\nOnce the product has been quarantined, please complete and return the enclosed response form as soon as possible by fax to: 518-725-0207, Attn: Quality Assurance. In addition, if you find any product that corresponds to the lot numbers given, please contact the Customer Service Department so that Epimed can arrange for replacement/credit (518-725-0209 or 518-514-1891).\n\nFurther questions, please call (518) 725-0209.", "product_quantity": "576 units", "distribution_pattern": "US Distribution to the states of : AL, AK, FL, IN, TN & TX", "openfda": { "device_name": "Needle, Conduction, Anesthetic (W/Wo Introducer)", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5150", "device_class": "2", "k_number": [ "K163216", "K073222", "K072005", "K203668", "K070354", "K083909", "K951411", "K111374", "K170112", "K950820", "K081864", "K193131", "K110194", "K823692", "K043467", "K000495", "K163292", "K980536", "K023218", "K813165", "K080603", "K920305", "K843313", "K894880", "K951312", "K002405", "K183316", "K100241", "K163435", "K952275", "K173155", "K945965", "K050499", "K894881", "K935255", "K171968", "K895453", "K160295", "K250774", "K172410", "K212982", "K113207", "K011122", "K093209", "K160297", "K854149", "K053318", "K061210", "K853478", "K943649", "K911260", "K170435", "K241953", "K022029", "K942863", "K141126", "K910652", "K901810", "K940061", "K151069", "K133632", "K013610", "K212328", "K160296", "K121812", "K854816", "K192914", "K173110", "K910791", "K131006", "K923003", "K101728", "K951265", "K091818", "K120475", "K822630", "K040965", "K150266", "K173321", "K000722", "K171518", "K243525", "K112515", "K993619", "K932400", "K090261", "K020934", "K932569", "K172823", "K903224", "K190026", "K990519", "K931644", "K961444", "K013892", "K063380", "K073516", "K082772", "K832233", "K951928", "K901811", "K211085", "K151072", "K944907", "K813179", "K121846", "K080140", "K911202", "K811963", "K063350", "K160294", "K962886", "K043500", "K011209", "K030618", "K243682", "K241954", "K032981", "K961152", "K851478", "K972595", "K142553", "K061394", "K191290", "K813236", "K041843", "K961151", "K042979", "K063071", "K013231", "K925831", "K944906", "K091758", "K081446", "K951949", "K983620", "K832126", "K894882", "K921288", "K243690", "K894878", "K894879", "K030562", "K820047", "K946047", "K850111", "K944905", "K210978", "K911221", "K921683", "K944908", "K240253" ], "registration_number": [ "", "1644312", "1000587249", "2032521", "3029901632", "3005580113", "3001845648", "3005012805", "1000393132", "1319639", "2320762", "1054241", "3015859709", "1000563940", "3006425876", "3007421133", "3012334073", "3003898360", "9615480", "3015173212", "3015058854", "3006787036", "3011237704", "3044026004", "3023155873", "3006082230", "3006271008", "3009241989", "3005941719", "1224960", "3035642068", "3030626857", "9680591", "3010592727", "1721676", "3020983482", "3008132398", "3045816907", "3002682307", "1422634", "3007441619", "3003152976", "1055236", "2025816", "9680222", "9616567", "1047429", "9615588", "3006345872", "2243072", "3004111573", "1423507", "1643817", "3000268902", "3019729537", "3013764800", "1056553", "9610825", "1030451", "1211566", "3011237770", "3006561161", "3013557562", "1043214", "2523676", "3002808466", "3010041511", "9680425", "3017567825", "1037885", "3010966701", "3010131137", "1820334", "3001124136", "3013188547", "2618282", "3009518015", "3012502601", "9680794", "2030624", "2032112", "9612086", "1828424", "3013298431", "3040339315", "3040313905", "3004076349", "3004365956", "2521402", "3010055973", "1417592", "1928237", "3011137372", "1061124", "2433012", "9617604", "3012421607", "1316297", "2011171", "3017210488", "3009526575", "1417485", "3009039068", "3007207906", "2027619", "1221435", "3011270181", "3012552122", "3015967359", "1722686", "1832216", "3009265194", "3038356900", "1643059", "3012494290", "1625425", "1047843", "3009888344", "1420054", "3006260740", "3014579161", "3002807314", "9614709", "8020785", "3013162291", "9611481", "9680448", "9614747", "3010321647", "9681709", "1018233", "1018470", "3012809732", "9611612", "3004605321", "3043226252", "9610993", "3011625895" ], "fei_number": [ "", "1000587249", "3029901632", "3005580113", "3001845648", "3005012805", "1000393132", "3002807847", "3015859709", "3002558692", "3003040625", "1000117748", "1000563940", "3006425876", "3007421133", "3012334073", "3003898360", "3003574398", "3015173212", "3015058854", "3003793605", "3006787036", "3011237704", "1000138054", "3044026004", "3023155873", "3002807111", "3006082230", "2649711", "3006271008", "3009241989", "3000206435", "3035642068", "3030626857", "3010592727", "1721676", "3020983482", "3045816907", "3002806575", "3002682307", "3007441619", "3003152976", "3003076831", "2025816", "1047429", "3006345872", "2243072", "3004111573", "1643817", "3000268902", "3019729537", "3013764800", "1030451", "1211566", "3011237770", "1000512168", "3008002452", "3006561161", "3013557562", "1043214", "1000112877", "2523676", "3002808466", "1000112968", "3010041511", "3017567825", "1037885", "3010966701", "3010131137", "1820334", "3001124136", "3013188547", "3005732259", "3009518015", "3012502601", "3002807091", "1828424", "3013298431", "3040339315", "3040313905", "3004076349", "3004365956", "2521402", "1000514656", "3010055973", "1417592", "3003154916", "1928237", "2433012", "3012421607", "3007596547", "1316297", "3002808374", "2011171", "3002807220", "3017210488", "3009526575", "1417485", "3009039068", "3003886545", "3007207906", "2027619", "1221435", "3011270181", "3012552122", "3003737899", "3015967359", "1832216", "3009265194", "3038356900", "1643059", "3012494290", "1625425", "1047843", "3009888344", "1000220636", "3009384766", "1420054", "3006260740", "3014579161", "1000132370", "3002807314", "3000204727", "3002806469", "3013162291", "3001738911", "3003560965", "3010321647", "3002963732", "3003803331", "3009291251", "1018233", "1018470", "3012809732", "3004605321", "3043226252", "3011625895", "3005747797" ] } } ] }