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FDA (Device enforcement)Recalled 2023-11-15class ii

SoClean, Inc: SoClean 3, REF SC1400, Automated Supplemental Sleep Equipment 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: 40,075 Lot/code info: UDI: (01)00858242007147

UPC codes

00858242007147

Source

Official record: FDA (Device enforcement)

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

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