FDA-Device2024-01-17Class II
SoClean 3, REF SC1400, Automated Supplemental Sleep Equipment Maintenance System
SoClean, Inc
Hazard
New User Manual with additional instructions for use and a hose and mask adapter provided by the device manufacturer. This voluntary recall is intended to help reduce potential health risks of exposure to ozone gas after the use of a SoClean device.
Sold states
Worldwide distribution - United States Nationwide and the countries of Argentina, Australia, Austria, Belgium, Canada, Chile, Colombia, Egypt, El Salvador, England, France, Germany, Hong Kong, Isle of Man, Israel, Italy, Japan, Jordan, Korea, Lithuania, Mexico, New Zealand, Portugal, Russia, Saudi Arabia, Seoul, Singapore, Spain, Sri Lanka, Switzerland, Thailand, Netherlands, Turkey, United Arab Emirates, and United Kingdom.
Affected count
40,075
Manufactured in
1 Vose Farm Rd, Peterborough, NH, United States
Products
SoClean 3, REF SC1400, Automated Supplemental Sleep Equipment Maintenance System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0694-2024Don't want to check this manually?
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