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SoClean, Inc recalls SoClean 3, REF SC1400, Automated Supplemental Sleep Equipment Maintenance System
Recalled January 17, 2024 · FDA recall Z-0694-2024 · SoClean
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. · FDA Class II
Units
40,075
Sold at
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.
Description
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.
Product
SoClean 3, REF SC1400, Automated Supplemental Sleep Equipment Maintenance System
Manufacturer(s)
SoClean, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →