510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Z-0446-2007

REMstar Heated Humidifier ( Respiratory Gas Humidifer) Model numbers 1005792, U1005792, R1005792, SC1005792...

Respironics, Inc. / initiated 2006-10-25 / Terminated
FDA source (opens on fda.gov)

Respironics, Inc. began a recall of REMstar Heated Humidifier ( Respiratory Gas Humidifer) Model numbers 1005792, U1005792, R1005792, SC1005792, AC1005792, 1007861, R1007861, and JP1007861 on . The reason FDA records is "AC inlet connector failure that can result in thermal damage to the humidifier enclosure and/or ignition of materials external to the device". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0446-2007
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Respironics, Inc.
Product
REMstar Heated Humidifier ( Respiratory Gas Humidifer) Model numbers 1005792, U1005792, R1005792, SC1005792, AC1005792, 1007861, R1007861, and JP1007861.
Product code
BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
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 root 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.
Product codes and lots
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.