{ "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": "32416", "product_res_number": "Z-0826-04", "event_date_initiated": "2004-03-30", "event_date_posted": "2004-07-20", "recall_status": "Terminated", "event_date_terminated": "2004-06-17", "res_event_number": "28725", "product_code": "CHL", "k_numbers": [ "K022746" ], "product_description": "Stat Profile Critical Care Xpress (CCX) Analyzer\nCatalog Number: 35942", "code_info": "Domestic S/N: Y01C03200 Y01C03130 Y01104030 Y01104040 Y01104100 Y01104110 Y01304150 Y01304120 Y01104150 Y01104130 Y01104050 Y01104190 Y01104160 Y01104220 Y01204020 Y01204100 Y01204010 Y01204130 Y01204150 Y01204160 Y01703120 Y01304040 Y01304010 Y01304110  International S/N: Inst. S/N Y01204200 Y01304030 Y01304130 Y01304140 Y01304090 Y01304100 Y01104140 Y01204070 Y01204170 Y01104120 Y01C03150", "firm_fei_number": "1219029", "recalling_firm": "Nova Biomedical Corporation", "address_1": "200 Prospect St", "city": "Waltham", "state": "MA", "postal_code": "02453-3457", "additional_info_contact": "Paul MacDonald\n781-647-3700 Ext. 211", "reason_for_recall": "Incorrectly assembled pumps may result in inconsistent compression of the tubing causing erratic results or calibration problems", "root_cause_description": "Other", "action": "Nova Biomedical notified users by telephone on 3/31/04 and conducted follow-up by letter either by email or fax. On-site visit will be scheduled to replace the pump assembly.", "product_quantity": "35 units", "distribution_pattern": "CA, IL, LA, MA ,NJ, NY, OH, PA, TX\nInternational: Italy ,England, Japan,Turkey., U.A.E., Greece, Thailand, Switzerland, Finland, Saudi Arabia, Italy, Mexico, Trinidad, Ireland, France, Cyprus, Czech Republic, ,Germany", "openfda": { "k_number": [ "K820597", "K895181", "K860057", "K945240", "K954711", "K063376", "K832779", "K041874", "K012478", "K013729", "K043218", "K865036", "K991417", "K993789", "K954612", "K992859", "K891578", "K000103", "K131988", "K193246", "K935655", "K200492", "K953935", "K936081", "K093280", "K904513", "K771253", "K890827", "K914560", "K223857", "K973367", "K023567", "K031560", "K123748", "K982928", "K141907", "K240998", "K122539", "K760229", "K131703", "K221900", "K122642", "K812552", "K142898", "K131126", "K961657", "K935121", "K771822", "K840300", "K844781", "K160153", "K211559", "K252207", "K020297", "K800224", "K944089", "K014295", "K854608", "K130144", "K963964", "K831012", "K864445", "K160412", "K943643", "K853840", "K963800", "K831010", "K955793", "K810724", "K792230", "K841609", "K002290", "K831020", "K902267", "K022746", "K820744", "K760748", "K151978", "K833536", "K100777", "K200107", "K980991", "K940918", "K012058", "K111188", "K770736", "K961161", "K935830", "K980130", "K831019", "K884267", "K863880", "K922922", "K780716", "K831016", "K871397", "K120197", "K852676", "K813517", "K924758", "K831379", "K954482", "K002613", "K821483", "K882941", "K934907", "K990092", "K831021", "K173797", "K840468", "K936203", "K913927", "K002738", "K772307", "K882209", "K812090", "K831015", "K151982", "K133407", "K021515", "K771147", "K850360", "K980523", "K974396", "K223608", "K823570", "K914166", "K812623", "K924497", "K110648", "K853405", "K842519", "K904188", "K833534", "K935069", "K974526", "K840843", "K051804", "K832981", "K831024", "K173403", "K831025", "K984384", "K760969", "K831013", "K200986", "K800757", "K884143", "K192240", "K994346", "K823750", "K943570", "K932642", "K244014", "K961335", "K852790", "K881188", "K831018", "K873577", "K050423", "K946206", "K970710", "K922631", "K942616", "K061974", "K915087", "K895317", "K831023", "K110416", "K943882", "K021713", "K834601", "K810308", "K203790", "K122729", "K800271", "K142220", "K982277", "K080370", "K992834", "K151856", "K111897", "K781968", "K962021", "K903965", "K844295", "K831017", "K230285" ], "device_name": "Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1120", "device_class": "2", "registration_number": [ "2432235", "1219029", "1220972", "9610633", "3002807968", "2050012", "3015997711", "3006198300", "3012104670", "3005643513", "1219913", "2431530", "3037000637", "3002637618", "3014506106", "1222035", "1036362", "9610126", "3007490412", "3007662974", "1000455123", "1181121", "2245578", "3013513377", "3023162659", "1217183", "8030478", "3004102403", "3012817228", "1717966", "1220649", "3003971136", "3004959793", "3003795116" ], "fei_number": [ "2432235", "1219029", "3002806559", "1220972", "3002807968", "2050012", "3015997711", "3006198300", "3012104670", "3005643513", "1219913", "2431530", "3037000637", "3002637618", "3014506106", "1222035", "1036362", "3001576181", "3007490412", "3007662974", "1000455123", "1181121", "2245578", "3013513377", "3023162659", "3002806693", "1217183", "3004102403", "3012817228", "1717966", "1220649", "3003971136", "3004959793", "3003795116" ] } } ] }