{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "73818", "product_res_number": "Z-0162-2009", "event_date_initiated": "2008-08-07", "event_date_posted": "2008-10-27", "recall_status": "Terminated", "event_date_terminated": "2009-10-01", "res_event_number": "49566", "product_code": "BTA", "k_numbers": [ "K042134" ], "product_description": "GlobTek, Inc. Power Supply for Medical Use Part No: TR9CE4000LCP-Y-MED MODEL: GTM21097-5012, Made in China.\n\nIndicated for patients who would benefit from a suction device particularly as the device may promote wound healing, including patients who would benefit from vacuum assisted drainage and removal of infectious materials or other fluid from wounds under the influence of continuous pressure.", "code_info": "SSN: RoHS02492601 Last 4 digits of SSN identifies affected products: 05/08; 06/08; 07/08; 08/08; 09/08; 10/08; 11/08; 12/08; 13/08; 14/08 and 15/08.", "firm_fei_number": "3006760724", "recalling_firm": "Smith And Nephew, Inc. Wound Management Division", "address_1": "11775 Starkey Road", "city": "Largo", "state": "FL", "postal_code": "33773-4727", "additional_info_contact": "727-399-3785", "reason_for_recall": "External battery chargers used with the Version 29 VISTA Negative Pressure Wound Therapy pumps are failing to properly charge the pump's battery.", "root_cause_description": "Nonconforming Material/Component", "action": "Each consignee was notified by recall letter (Field Correction Notification) dated 8/7/08 via FEDEX overnight. Within five (5) working days of the date of the customer notification a Smith & Nephew representative will contact the customers to assess their inventory and schedule delivery of replacement battery chargers. \n\nContact Smith & Nephew, Inc. (Customer Care Center) at 1-800-876-1261 for for assistance.", "product_quantity": "2,550", "distribution_pattern": "Nationwide within U.S. and internationally to United Kingdom, New Zealand, Germany, Canada and Australia.", "openfda": { "k_number": [ "K840110", "K813095", "K930549", "K852646", "K843693", "K970186", "K242028", "K180863", "K090379", "K873462", "K981703", "K843750", "K141255", "K033179", "K253107", "K952806", "K040239", "K233901", "K993668", "K952632", "K850946", "K960492", "K980301", "K932051", "K926566", "K952103", "K820739", "K844200", "K941578", "K051758", "K103042", "K973268", "K934976", "K260134", "K851560", "K221042", "K231063", "K951423", "K984363", "K250697", "K853917", "K920628", "K081185", "K253629", "K141553", "K813312", "K873940", "K841903", "K862569", "K953132", "K090445", "K921107", "K042943", "K181667", "K954287", "K062801", "K232831", "K041154", "K921611", "K944116", "K940934", "K853909", "K992026", "K821321", "K933757", "K954264", "K842204", "K093241", "K971749", "K862751", "K243138", "K933902", "K944818", "K220126", "K812020", "K251101", "K891129", "K241799", "K932494", "K950495", "K052650", "K951326", "K041405", "K043544", "K080212", "K982371", "K180606", "K874157", "K130123", "K130131", "K981602", "K941961", "K862875", "K241202", "K153459", "K153663", "K980454", "K201203", "K241852", "K013116", "K832100", "K932031", "K841399", "K941096", "K260892", "K173389", "K971107", "K251450", "K013585", "K870094", "K964997", "K140179", "K011601", "K945929", "K222856", "K244033", "K944399", "K203135", "K854844", "K122619", "K983552", "K951729", "K061133", "K831007", "K260147", "K021368", "K130210", "K883582", "K840803", "K922176", "K843644", "K931348", "K963775", "K062610", "K170533", "K061205", "K080745", "K860030", "K071607", "K910271", "K954286", "K041199", "K223373", "K221676", "K980392", "K810490", "K092903", "K260473", "K832274", "K052626", "K820338", "K222547", "K831085", "K161002", "K871570", "K833785", "K791349", "K965059", "K942033" ], "registration_number": [ "9610617", "3013758550", "3004050971", "1060680", "3010707607", "1220908", "3013298431", "1417592", "3004378299", "9610612", "2523148", "3015615738", "3011050570", "3038259592", "3005813597", "2022724", "3010202439", "3014827316", "1450908", "3027605322", "3007305485", "3003781173", "3003509351", "3006174295", "3015924074", "3019924", "2032112", "2134752", "1219343", "3010659128", "9614936", "3005803793", "3014342096", "3006142527", "3004443928", "3006789357", "3016661562", "3012684779", "9613895", "9617787", "8010573", "2020550", "3011716786", "3023876581", "3002807523", "3021595514", "2132111", "1000122786", "9610861", "3009538961", "1419937", "3012797688", "3042156936", "2024022", "3013095415", "3020476987", "3013556777", "3011816507", "3005527904", "9680961", "1043214", "1649660", "1721676", "3006617533", "3029871637", "3004727197", "3004464325", "3010034780", "3004145393", "9614434", "1000604079", "3014718111", "3008837339", "3009039068", "3004993040", "3013857114", "3010079067", "3017493034", "9680741", "3016904853", "3007360714", "3017435705", "9617543", "3025428426", "3031563234", "3012322232", "3017520736", "3021376102", "3014273557", "9611174", "3038634684", "3007143859", "3005168196", "3016591327", "3015177409", "1419185", "1924066", "3005146144", "3026986849" ], "fei_number": [ "3013758550", "3004050971", "3010707607", "1220908", "3013298431", "3003272793", "1000208624", "1417592", "3004378299", "2523148", "3015615738", "3011050570", "3038259592", "3005813597", "3002806315", "2022724", "3014827316", "1450908", "3027605322", "3007305485", "3003781173", "3003509351", "3006174295", "3015924074", "3003076831", "3019924", "3005479955", "1219343", "3010659128", "3005803793", "3014342096", "3006142527", "1000121355", "3002808273", "3002808224", "3005601686", "3004443928", "3006789357", "3016661562", "3012684779", "1000162602", "2020550", "3011716786", "3023876581", "3002807523", "3021595514", "3002808268", "1000122786", "3009538961", "1419937", "3012797688", "3042156936", "2024022", "3013095415", "3020476987", "3013556777", "3007475226", "3011816507", "3005527904", "1043214", "1721676", "3006617533", "3004145393", "3004727197", "3029871637", "3010034780", "3004464325", "3001451796", "3003169291", "3002345941", "1000604079", "3003007822", "3008837339", "3009039068", "3002807836", "3004993040", "3013857114", "3010079067", "3017493034", "1000140026", "3016904853", "3007360714", "3017435705", "3025428426", "3031563234", "3012322232", "3017520736", "3021376102", "3014273557", "3038634684", "3007143859", "3005168196", "3016591327", "3003327833", "3015177409", "1419185", "1924066", "3005146144", "3026986849" ], "device_name": "Pump, Portable, Aspiration (Manual Or Powered)", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4780", "device_class": "2" } } ] }