REMstar Heated Humidifer Main PCA Repair Kit, Part number 1006265
This recall has been terminated (originally issued January 10, 2007).
- Company
- Respironics, Inc.
- Recall Initiated
- October 25, 2006
- Posted
- January 10, 2007
- Terminated
- December 15, 2009
- Recall Number
- Z-0447-2007
- Quantity
- 235 units
- Firm Location
- Murrysville, PA
- Official Source
- View on FDA website ↗
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
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.
Lot / Code Info
Part number 1006265, Lot number 020613, 020614, 020801, 020823, 020926, 021121, 021226, 030130, 030303, 030320, 303401, 303417, 030423, 030514, and 030611.
Root Cause
Other
Action Taken
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.