Class 2 Device Recall REMstar Heated Humidifier

• Date Initiated by Firm: October 25, 2006
• Date Posted: January 10, 2007
• Recall Status: Terminated on December 15, 2009
• Recall Number: Z-0446-2007
• Recall Event ID: 36649
• 510(K)Number: K010263
• Product Classification: Humidifier - Product Code BTT
• Product: REMstar Heated Humidifier ( Respiratory Gas Humidifer) Model numbers 1005792, U1005792, R1005792, SC1005792, AC1005792, 1007861, R1007861, and JP1007861.
• Code Information: Model numbers 1005792, U1005792, R1005792, SC1005792, AC1005792, 1007861, R1007861, and JP1007861. Serial numbers range affected H045582 through H239662. Individual serial numbers are: H000524, H000546, H00593, H000596, H000599, H000967, H001052, H001054, H001320, H001394, H001454, H001537, H001555, H001589, H001614, H001631, H001964, H002120, H002421, H002491, H002582, H002794, H002817, H002822, H002978, H003083, H003590, H003665, H003739, H004117, H004747, H004804, H004971, H004978, H005289, H005405, H005411, H005416, H005534, H005550, H005577, H005681, H005876, H006214, H006448, H006665, H006700, H006711, H006819, H007080, H007104, H007683, H007828, H007907, H008213, H008295, H008348, H008452, H008549, H008588, H008733, H008956, H009282, H009670, H009797, H009838, H009858, H009894, H010883, H011283, H011636, H012040, H012080, H012120, H012288, H012621, H012737, H012819, H013327, H013346, H013727, H014040, H014432, H014449, H014541, H014565, H014752, H014753, H014898, H015446, H015760, H015761, H015848, H015859, H015873, H016071, H016112, H016276, H016552, H016629, H016665, H016753, H016895, H016913, H016926, H017170, H017195, H017270, H017294, H017382, H017483, H017905, H018031, H018037, H018435, H018717, H018735, H018963, H018965, H018995, H019041, H019069, H019088, H019348, H019362, H019371, H019385, H019586, H019685, H019786, H019807, H019837, H019839, H019867, H019923, H019985, H020053, H020253, H020502, H020518, H020538, H020562, H020572, H020583, H020597, H020606, H020647, H020713, H020727, H020739, H020754, H020889, H021619, H021781, H021838, H021943, H022085, H022283, H022286, H022297, H022366, H022369, H022412, H022512, H022514, H023004, H023159, H023331, H023583, H023602, H023720, H023745, H023791, H023797, H023821, H023912, H024779, H025127, H025226, H025304, H025317, H025321, H025398, H025434, H025560, H025969, H026008, H026132, H026156, H026158, H026199, H026202, H026206, H026207, H026364, H026405, H026425, H026726, H026759, H027046, H027122, H027239, H027478, H027507, H027694, H027765, H027904, H027986, H028025, H028080, H028282, H028408, H028549, H028594, H029078, H029429, H029529, H029538, H029564, H029808, H029875, H029923, H030136, H030151, H030244, H030407, H030491, H030672, H030937, H031059, H031064, H031089, H031119, H031220, H031245, H031255, H031270, H031300, H031370, H031386, H031434, H031484, H031486, H031602, H031766, H031857, H031893, H032112, H032130, H032289, H032298, H032418, H032672, H032762, H032788, H032794, H032806, H032923, H033048, H033134, H033171, H033286, H033305, H033400, H034422, H034493, H034624, H034687, H034704, H035098, H035138, H035270, H035295, H035801, H035954, H036042, H036268, H036440, H036655, H036878, H037043, H037203, H037235, H037343, H037433, H037585, H037592, H037897, H038061, H038147, H038170, H038254, H038500, H038507, H038657, H038720, H038789, H038915, H038921, H039024, H039084, H039157, H039231, H039420, H039431, H039542, H039922, H040025, H040133, H040300, H040349, H040403, H040462, H040480, H040493, H040590, H040912, H041200, H041254, H041298, H041322, H041346, H041595, H041879, H041884, H041886, H041892, H041896, H042261, H042419, H042420, H042527, H042912, H042992, H042997, H043012, H043461, H043494, H043692, H043763, H043877, H043973, H043991, H044274, H044317, H044338, H044128, H044185, H044414, H044468, H044480, H044544, H044565, H044759, H044849, H044878, H044909, H044954, H045276, H045381, H045406, H045466, H045486, H045494, H045498, and HO45514.
• Recalling Firm/ Manufacturer: Respironics, Inc.; 1001 Murry Ridge Ln; Murrysville PA 15668-8550
• For Additional Information Contact: Katherine dePadua; 724-387-5200
• Manufacturer Reason for Recall: AC inlet connector failure that can result in thermal damage to the humidifier enclosure and/or ignition of materials external to the device
• FDA Determined Cause: Other
• Action: The recalling firm issued a recall letter dated 10/25/06 to their domestic and Canadian dealers informing them of the problem and the need to contact the end users. These dealers were given two options: 1) contact the end user by forwarding a letter the recalling firm provided or 2) contacting the third party company with their distribution list. The recalling firm issued a recall letter dated 10/25/06 regarding the service repair kit and the need to contact end users that had the device repaired using this kit. The recalling firm issued a recall letter date 10/25/06 to the international customers informing them of the problem, contact the end users, and the need to destroy the recalled part.
• Quantity in Commerce: 172,000 units
• Distribution: Worldwide Distribution ---- including USA and countries of Denmark, Austria, France, Canada, Netherlands, Japan, Hong Kong, Austrailia, Great Britain, Spain, Belgium, Germany, Poland, Ireland, Portugal, Saudia Arabia, Korea, Mexico, Finland, Taiwan, Philippines, Iceland, Brazil, Kuwait, New Zealand, Chile, India, Egypt, Norway, Turkey, Jordan, Thailand, Hungary, Russia, Peru, South Africia, Israel, Czech, Pakistan, Lebanon, Venezuela, Sweden, United Arab Emirates, Qatar, Slovakia, Bulgaria, Bermuda, and Colombia.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = BTT