FDAFDA · Food and drugs·Recall number Z-0694-2024
SoClean 3, REF SC1400, Automated Supplemental Sleep Equipment Maintenance System
Published January 17, 2024 · Recall initiated: November 15, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- SoClean, Inc
- Distributor
- 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.
- Lot
- UDI: (01)00858242007147
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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