FDA Device

REMstar Heated Humidifier ( Respiratory Gas Humidifer) Model numbers 1005792, U1005792, R1005792, SC1005792, AC1005792, 1007861, R1007861, and JP1007861.

Hazard

AC inlet connector failure that can result in thermal damage to the humidifier enclosure and/or ignition of materials external to the device

What You Should Do

Remedy

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.

Products

REMstar Heated Humidifier ( Respiratory Gas Humidifer) Model numbers 1005792, U1005792, R1005792, SC1005792, AC1005792, 1007861, R1007861, and JP1007861.
Brand
Respironics, Inc.
UPC
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.

Units Affected

172,000 units