{ "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": "140532", "product_res_number": "Z-0159-2016", "event_date_initiated": "2015-09-16", "event_date_posted": "2015-10-23", "recall_status": "Terminated", "event_date_terminated": "2016-03-21", "res_event_number": "72305", "product_code": "CHL", "k_numbers": [ "K945240" ], "product_description": "CC cartridges for IRMA TRUPOINT Blood Gas Analyzer, PN 039903.\nThe CC Cartridge are single use, disposable, in vitro diagnostics intended for point of care (POC), professional, use with the IRMA TRUpoint Blood Analysis System.", "code_info": "ASBEZ ASCXE ASEMB ASHWQ ASJMY ASLGI ASMXR ASOQO ASRXC ASTQR ASWZI", "firm_fei_number": "1000115726", "recalling_firm": "LifeHealth, LLC", "address_1": "2656 Patton Rd", "city": "Roseville", "state": "MN", "postal_code": "55113-1136", "additional_info_contact": "Scott Blomberg\n651-638-1114", "reason_for_recall": "May report values outside the published performance specifications for pH. After a certain point in shelf life, the pH sensor may give results that are falsely elevated. The discrepancy is greater as shelf life progresses and can be seen on the aqueous controls before the blood.", "root_cause_description": "Nonconforming Material/Component", "action": "Consignees were sent a LifeHealth \"Urgent Medical Device Recall\" letter dated September 16, 2015. The letter described the problem and the product involved in the recall. The letter described the Risk to Health, Action to be taken and Other Information. Consignees were advised to discontinue use and destroy all stock on hand. Requested consignees to complete and return the Verification Form to LifeHealth. For additional information contact Nancy Ring at 1-855-762-8978 or 651-638-1000, Monday through Friday, 8:30 AM to 4:30 PM, Central Time or see our website at www.lifehealthmed.com.", "product_quantity": "4659 boxes of 25. (116475 cartridges)", "distribution_pattern": "US: Nationwide \n(AL, AR, CA, CO, FL, IL, IN, IA, KS, KY, MD, MA,MI, MN, MS, MO, NE, NJ, NY,NC, OH, OK, PA, TN, TX, VA)\n\nOUS: ALBANIA, BELGIUM, BOLIVIA, CANADA, CHILE, CHINA, DENMARK. DOMINICAN REPUBLIC, ECUADOR, EGYPT, ENGLAND, ESTONIA, PHILIPPINES, FRANCE, GERMANY, GREECE, ICELAND, INDONESIA, IRELAND, ITALY, JAMAICA, JAPAN, MOROCCO, NETHERLANDS, NORWAY, PERU, PORTUGAL, SOUTH AFRICA, SOUTH KOREA, SPAIN, TAIWAN, TUNISIA, TURKEY, UNITED ARAB EMIRATES, VIETNAM.", "openfda": { "k_number": [ "K946206", "K840468", "K050423", "K914560", "K122729", "K844781", "K831021", "K831016", "K970710", "K932642", "K771253", "K760969", "K823750", "K980130", "K810724", "K934907", "K973367", "K980991", "K771822", "K935830", "K813517", "K240998", "K953935", "K820744", "K852790", "K142220", "K173403", "K021515", "K924497", "K954612", "K151978", "K160412", "K922922", "K831025", "K080370", "K991417", "K093280", "K021713", "K840843", "K012478", "K831010", "K940918", "K943882", "K031560", "K882941", "K842519", "K014295", "K903965", "K820597", "K760229", "K022746", "K110648", "K831379", "K100777", "K130144", "K122539", "K000103", "K844295", "K860057", "K133407", "K223857", "K962021", "K831017", "K160153", "K173797", "K850360", "K954482", "K151982", "K041874", "K002738", "K812090", "K882209", "K840300", "K823570", "K904188", "K831015", "K863880", "K002613", "K984384", "K051804", "K193246", "K935655", "K990092", "K963964", "K881188", "K111897", "K922631", "K993789", "K954711", "K800224", "K992859", "K871397", "K890827", "K012058", "K915087", "K200986", "K913927", "K760748", "K131126", "K831024", "K792230", "K891578", "K854608", "K936203", "K043218", "K873577", "K834601", "K884143", "K955793", "K200107", "K945240", "K192240", "K131988", "K980523", "K982928", "K122642", "K800271", "K961657", "K244014", "K812552", "K942616", "K821483", "K924758", "K833534", "K023567", "K943570", "K812623", "K961335", "K831019", "K944089", "K895317", "K002290", "K110416", "K832779", "K142898", "K865036", "K831023", "K200492", "K895181", "K963800", "K211559", "K853405", "K935069", "K832981", "K131703", "K772307", "K982277", "K013729", "K831020", "K852676", "K831013", "K120197", "K992834", "K935121", "K833536", "K904513", "K864445", "K841609", "K252207", "K853840", "K810308", "K936081", "K771147", "K203790", "K151856", "K914166", "K020297", "K230285", "K141907", "K063376", "K781968", "K111188", "K902267", "K943643", "K780716", "K061974", "K884267", "K974526", "K800757", "K123748", "K974396", "K221900", "K770736", "K223608", "K961161", "K831012", "K994346", "K831018" ], "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": [ "3002637618", "1220972", "3005643513", "3013513377", "3003795116", "1036362", "2431530", "3004102403", "9610633", "1217183", "3012104670", "2245578", "3004959793", "1000455123", "3014506106", "2432235", "1717966", "2050012", "3023162659", "3015997711", "1219029", "3003971136", "9610126", "1220649", "1181121", "1222035", "3037000637", "1219913", "8030478", "3007662974", "3007490412", "3002807968", "3012817228", "3006198300" ], "fei_number": [ "3002637618", "1220972", "3005643513", "3013513377", "3003795116", "1036362", "2431530", "3004102403", "1217183", "3012104670", "2245578", "3004959793", "1000455123", "3014506106", "2432235", "1717966", "2050012", "3023162659", "3015997711", "1219029", "3003971136", "1220649", "1181121", "1222035", "3037000637", "1219913", "3007662974", "3007490412", "3002806693", "3002807968", "3012817228", "3006198300", "3001576181", "3002806559" ] } } ] }