Z-0447-2007

REMstar Heated Humidifer Main PCA Repair Kit, Part number 1006265

Name: Z-0447-2007 REMstar Heated Humidifer Main PCA Repair Kit, Part number 1006265
Creator: Respironics, Inc.
Published: 2006-10-25
License: https://open.fda.gov/license/

Respironics, Inc. / initiated 2006-10-25 / Terminated

FDA source

Respironics, Inc. began a recall of REMstar Heated Humidifer Main PCA Repair Kit, Part number 1006265 on 2006-10-25. 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 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0447-2007
Status: Terminated
Initiated: 2006-10-25
Posted: 2007-01-10
Terminated: 2009-12-15
Recalling firm: Respironics, Inc.
Product: REMstar Heated Humidifer Main PCA Repair Kit, Part number 1006265
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: 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.
Product codes and lots: Part number 1006265, Lot number 020613, 020614, 020801, 020823, 020926, 021121, 021226, 030130, 030303, 030320, 303401, 303417, 030423, 030514, and 030611.

Product code BTT

K010263Class IIRemstar Plus CPAP SystemRespironics, Inc. / cleared 2001-03-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)