Device product
SoClean 2, REF SC1200, Supplemental Hose and Mask Maintenance System.
Z-0695-2024
Product summary
- Firm
- SoClean, Inc
- Event
- Event 93570
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2,339,352
- Official record key
device-enforcement:Z-0695-2024
Official wording
Reason: 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.
Code information: UPC: 187293000860
Distribution pattern: 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.
Derived failure modes
-
Unknown
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.