BEUDAMED
    FDA Enforcement Class II Ongoing

    SoClean 3, REF SC1400, Automated Supplemental Sleep Equipment Maintenance System

    Recall: Z-0694-2024 · Reported January 17, 2024

    Enforcement

    Recall Number
    Z-0694-2024
    Event ID
    93570
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    SoClean, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 17, 2024
    Initiation Date
    November 15, 2023
    Classification Date
    January 10, 2024
    Address
    1 Vose Farm Rd, Peterborough, NH, 03458-2128, United States

    Description

    SoClean 3, REF SC1400, Automated Supplemental Sleep Equipment Maintenance System

    Reason

    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.

    Code Info

    UDI: (01)00858242007147

    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.

    Quantity

    40,075