{ "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": "72004", "product_res_number": "Z-0071-2008", "event_date_initiated": "2007-05-28", "event_date_posted": "2008-09-29", "recall_status": "Terminated", "event_date_terminated": "2008-09-29", "res_event_number": "48721", "product_code": "BTA", "k_numbers": [ "K040239" ], "product_description": "NeoMedix Trabectome I/A Console, Model Number 550014, surgical aspirator", "code_info": "Model Number 550014; Lot Number 061205-1; Serial Numbers: 10117, 10119, 10120, 10122, 10124, 100129, and 10133.", "firm_fei_number": "3003698071", "recalling_firm": "Neomedix Corp", "address_1": "15042 Parkway Loop Ste A 15042 Parkway Loop", "address_2": "Ste A", "city": "Tustin", "state": "CA", "postal_code": "92780-6528", "additional_info_contact": "949-258-8355", "reason_for_recall": "Failure of irrigation flow: The pinch valve in a few pumps may not consistently open to allow irrigation flow. In over 450 surgeries, the firm confirmed one instance of a valve that did not open. The electrically activated pinch valve in the NeoMedix Trabectome I/A pump activates irrigation flow to the eye during Trabectome surgery.", "root_cause_description": "Nonconforming Material/Component", "action": "On May 31, 2007 NeoMedix mailed a Customer letter to all consignees informing them of the hazard. The letter also indicated to the customers they NeoMedix has developed a minor modification/upgrade that is designed to assure that the pinch valve opens at the appropriate time. The customers were instructed this modification requires return of their existing pump for modification and testing at the firm's facility before its return. In the event that surgeries have already been scheduled, NeoMedix will provide a loaner unit until the suspect unit can be modified and returned to you.\nThe letter also indicated the cost of the modification and/or use of a loaner unit will be entirely at NeoMedix expense. You will be contacted to establish the details of implementing this modification.", "product_quantity": "7", "distribution_pattern": "Nationwide to: CA, HI, IA, NY & PA", "openfda": { "k_number": [ "K231063", "K812020", "K860030", "K933902", "K941578", "K170533", "K982371", "K853909", "K241202", "K870094", "K940934", "K992026", "K842204", "K201203", "K862875", "K222856", "K971107", "K841399", "K843693", "K853917", "K922176", "K062801", "K963775", "K873940", "K934976", "K933757", "K926566", "K951729", "K244033", "K260892", "K253107", "K920628", "K921107", "K832274", "K062610", "K153459", "K932051", "K941096", "K874157", "K090379", "K910271", "K831085", "K941961", "K954264", "K840803", "K921611", "K973268", "K260147", "K993668", "K950495", "K080745", "K013585", "K951326", "K052650", "K253629", "K981602", "K033179", "K181667", "K840110", "K850946", "K122619", "K203135", "K180606", "K241852", "K061133", "K221042", "K090445", "K980454", "K042943", "K071607", "K980392", "K841903", "K960492", "K813312", "K251101", "K954287", "K831007", "K220126", "K061205", "K883582", "K141255", "K930549", "K952806", "K080212", "K130123", "K153663", "K954286", "K820338", "K092903", "K180863", "K971749", "K820739", "K052626", "K051758", "K851560", "K951423", "K852646", "K081185", "K932031", "K242028", "K983552", "K093241", "K021368", "K813095", "K013116", "K945929", "K810490", "K041199", "K232831", "K223373", "K221676", "K953132", "K932494", "K843750", "K233901", "K843644", "K251450", "K970186", "K791349", "K241799", "K891129", "K873462", "K173389", "K952103", "K854844", "K832100", "K862751", "K984363", "K141553", "K871570", "K130210", "K833785", "K981703", "K844200", "K011601", "K942033", "K222547", "K103042", "K041154", "K862569", "K260473", "K944399", "K140179", "K260134", "K243138", "K821321", "K043544", "K931348", "K130131", "K040239", "K964997", "K041405", "K965059", "K944818", "K161002", "K952632", "K944116", "K250697", "K980301" ], "registration_number": [ "3011816507", "3005803793", "1000604079", "9613895", "3012684779", "1060680", "9611174", "3010034780", "3004993040", "3003509351", "3042156936", "3014273557", "3006142527", "3010079067", "3004145393", "3006789357", "3023876581", "3013758550", "1450908", "1924066", "3006174295", "1721676", "9617787", "3017520736", "3026986849", "9610612", "9614434", "3013556777", "3038634684", "2134752", "1419185", "9610861", "3027605322", "3012322232", "3017435705", "3038259592", "9680961", "1043214", "3019924", "3013857114", "2022724", "3007305485", "3010707607", "3005813597", "9680741", "3014718111", "3031563234", "3005527904", "2032112", "3013298431", "3029871637", "3016661562", "3005168196", "1417592", "2132111", "1220908", "2024022", "3011716786", "3015615738", "3014827316", "3009538961", "3009039068", "3004378299", "3004050971", "9617543", "1219343", "3004464325", "3015924074", "8010573", "3025428426", "3014342096", "3021595514", "1419937", "3002807523", "3008837339", "3004727197", "3013095415", "3005146144", "1000122786", "3020476987", "3010202439", "3012797688", "3004443928", "9614936", "3003781173", "2020550", "3011050570", "3017493034", "3007360714", "1649660", "3021376102", "3007143859", "3006617533", "3015177409", "9610617", "3016904853", "3016591327", "3010659128", "2523148" ], "fei_number": [ "3011816507", "3005803793", "1000604079", "3012684779", "3003327833", "3010034780", "3004993040", "3003509351", "3042156936", "3014273557", "3006142527", "3003272793", "3005479955", "3010079067", "3004145393", "3006789357", "3023876581", "3013758550", "1450908", "1924066", "3006174295", "1000162602", "3002808224", "1721676", "3017520736", "3026986849", "3001451796", "3013556777", "3003076831", "3038634684", "1419185", "3007475226", "3027605322", "3012322232", "3017435705", "3038259592", "3002806315", "1043214", "3019924", "3013857114", "2022724", "1000140026", "3007305485", "3010707607", "1000121355", "3005813597", "3031563234", "3005527904", "3013298431", "3029871637", "3016661562", "3005168196", "1417592", "1220908", "2024022", "3011716786", "3015615738", "3014827316", "3009538961", "3009039068", "3004378299", "3004050971", "1219343", "3004464325", "3005601686", "3015924074", "3003007822", "3025428426", "3014342096", "3002808268", "3003169291", "3002808273", "3021595514", "1419937", "3002807523", "3008837339", "3004727197", "1000208624", "3013095415", "3005146144", "3002345941", "1000122786", "3020476987", "3012797688", "3004443928", "3003781173", "2020550", "3011050570", "3017493034", "3007360714", "3002807836", "3021376102", "3007143859", "3006617533", "3015177409", "3016904853", "3016591327", "3010659128", "2523148" ], "device_name": "Pump, Portable, Aspiration (Manual Or Powered)", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4780", "device_class": "2" } } ] }