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U.S. Department of Health and Human Services

Class 2 Device Recall REMstar Heated Humidifier main PCA Repair Kit

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  Class 2 Device Recall REMstar Heated Humidifier main PCA Repair Kit see related information
Date Initiated by Firm October 25, 2006
Date Posted January 10, 2007
Recall Status1 Terminated 3 on December 15, 2009
Recall Number Z-0447-2007
Recall Event ID 36649
510(K)Number K010263  
Product Classification Humidifier - Product Code BTT
Product REMstar Heated Humidifer Main PCA Repair Kit, Part number 1006265
Code Information Part number 1006265, Lot number 020613, 020614, 020801, 020823, 020926, 021121, 021226, 030130, 030303, 030320, 303401, 303417, 030423, 030514, and 030611.
Recalling Firm/
Respironics, Inc.
1001 Murry Ridge Ln
Murrysville PA 15668-8550
For Additional Information Contact Katherine dePadua
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 2
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 235 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 and Original Applicant = RESPIRONICS, INC.