Home / Recalls / SoClean, Inc / Z-0695-2024

Z-0695-2024 Class II Ongoing

Recalled by SoClean, Inc — Peterborough, NH

FDA device recall Z-0695-2024 was initiated by SoClean, Inc on November 15, 2023 and is designated Class II. 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 exposur… The recall status is ongoing. Affected quantity: 2,339,352.

Recall Details

Product Type: Devices
Report Date: January 17, 2024
Initiation Date: November 15, 2023
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2,339,352

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.

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.

Code Information

UPC: 187293000860