SoClean 2, REF SC1200, Supplemental Hose and Mask Maintenance System.
Reported: January 17, 2024 Initiated: November 15, 2023 #Z-0695-2024
Product Description
SoClean 2, REF SC1200, Supplemental Hose and Mask Maintenance System.
Reason for Recall
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.
Details
- Recalling Firm
- SoClean, Inc
- Units Affected
- 2,339,352
- Distribution
- 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.
- Location
- Peterborough, NH
Frequently Asked Questions
What product was recalled? ▼
SoClean 2, REF SC1200, Supplemental Hose and Mask Maintenance System.. Recalled by SoClean, Inc. Units affected: 2,339,352.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 17, 2024. Severity: Moderate. Recall number: Z-0695-2024.
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