SoClean, Inc: SoClean 2, REF SC1200, Supplemental Hose and Mask Maintenance System.

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.

Details from the source

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. 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 E Quantity: 2,339,352 Lot/code info: UPC: 187293000860

UPC codes

187293000860

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.