Recall Z-0447-2007 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Respironics, Inc.
REMstar Heated Humidifer Main PCA Repair Kit, Part number 1006265
| Date | Jan 10, 2007 (initiated Oct 25, 2006) |
| Status | Terminated |
| Reason | AC inlet connector failure that can result in thermal damage to the humidifier enclosure and/or ignition of materials external to the device |
| 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 custo |
| Quantity | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010263 | REMSTAR PLUS CPAP SYSTEM Respironics, Inc., Mar 29, 2001 |