{ "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. 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& 040204000114", "firm_fei_number": "3002806988", "recalling_firm": "Fisher & Paykel Healthcare Ltd", "address_1": "15 Maurice Paykel Place", "city": "Auckland", "country": "New Zealand", "reason_for_recall": "This firm has received Product Complaint Reports concerning bending of the pivot plate. The elevator base of the CosyCot Infant Warmer incorporates a pivot plate which forms part of the mechanism allowing the CosyCot to raise and lower in height. A bent pivot plate generally results in the Warmer being unable to elevate properly. Other component failures may result.", "root_cause_description": "Other", "action": "Fisher & Paykel Healthcare commenced sending out Product Correction Notifications letter via U.S. Postal Service certified \nmail October 9, 2006. This Product Correction Notice explained the nature of the problem and include a reminder of the maximum recommended weight of accessories. Two FAX Response Forms were provided, Part A for initial receipt of the Product Correction Notice and Part B for confirmation of the completed upgrade.", "product_quantity": "273 units in US & 9 in Canada", "distribution_pattern": "Nationwide and Canada", "openfda": { "k_number": [ "K853926", "K871178", "K935609", "K862921", "K921547", "K912921", "K840792", "K201628", "K812745", "K853351", "K971366", "K191425", "K871594", "K020966", "K881713", "K971198", "K120642", "K964401", "K971695", "K861781", "K925006", "K020219", "K101804", "K813408", "K851449", "K790137", "K946005", "K884283", "K915831", "K872742", "K871177", "K840858", "K913945", "K830748", "K950143", "K952800", "K884160", "K970074", "K931529", "K972885", "K840857", "K850069", "K885350", "K952801", "K950422", "K971461", "K072157", "K122267", "K243606", "K952807", "K003335", "K884285", "K033040", "K833802", "K881670", "K060461", "K200319", "K173516", "K952804", "K926030", "K090697", "K875270", "K790948", "K121625", "K865012", "K952803", "K910915", "K884280", "K942905", "K852943", "K940951", "K952805", "K120937", "K102227", "K863208", "K953489", "K213551", "K970686", "K942904", "K832637", "K921766", "K963058", "K002355", "K070377", "K970432", "K802365", "K123309", "K853794", "K934677", "K960080", "K012229", "K230278" ], "registration_number": [ "3030733800", "", "3012348048", "3004050971", "1055236", "3010838917", "1000617661", "3014220748", "3001104093", "1317188", "9617277", "3005934741", "9710602", "1057358", "3005652389", "9613793", "1043214", "3021559257", "1625392", "2510954", "2027062", "3008729547", "3007734888", "1314417", "1226711", "3036470679", "1054241", "9611500", "1000604079", "9611451", "1054713", "1034876", "2085602", "3012086037" ], "fei_number": [ "3030733800", "", "1000114111", "3012348048", "3004050971", "3023530182", "3010838917", "1000208608", "1000617661", "1000112877", "3014220748", "1317188", "3001104093", "3005934741", "3003338236", "3004846435", "1043214", "3021559257", "1000112968", "3006469671", "2510954", "2027062", "3008729547", "3003513129", "3007734888", "1314417", "3000210616", "3036470679", "1000604079", "3002806988", "1034876", "1000058335", "3012086037", "3003190524" ], "device_name": "Warmer, Infant Radiant", "medical_specialty_description": "General Hospital", "regulation_number": "880.5130", "device_class": "2" } } ] }