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Respironics REMstar heated CPAP humidifier

Medical device recall

The design of the electrical power inlet to the humidifier is faulty. 

Published
Level:Consumer
Class:III
Reference:RN-2006-0759
Date agreed:23 November 2006
Product:

Respironics REMstar heated CPAP humidifier

Serial numbers up to H239662 - manufactured between December 2001 and April 2003 only.

ARTG number:99688
Sponsor:The Mayo Group International Pty Ltd
Contact:1300 559 389
Reason:The design of the electrical power inlet to the humidifier is faulty. This may cause the humidifier to overheat the base of the AC inlet connection.

Letters are expected to be dispatched by the sponsor within two working days of the agreed date. Recall notices will appear in national newspapers from Tuesday 28 November 2006,

Classification system:

Class I defects are potentially life-threatening or could cause a serious risk to health.

Class II defects could cause illness or mistreatment, but are not Class I.

Class III defects may not pose a significant hazard to health, but withdrawal may be initiated for other reasons.

Class I & II recalls are considered to be safety related recalls.

Product types