BEUDAMED
    FDA Enforcement Class II Ongoing

    LightStrike Blackout Curtains, Part numbers; 610-00008, 610-00009, 610-00019, 610-00020, and 610-00024, used with the LightStrike Germ-Zapping Robots Models: PXUV4D, PXUV5D, LSMUV6-FT, or LSMUV6-SL, for whole room microbial reduction.

    Recall: Z-1615-2024 · Reported May 1, 2024

    Enforcement

    Recall Number
    Z-1615-2024
    Event ID
    94258
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    XENEX Disinfection Services Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 1, 2024
    Initiation Date
    March 18, 2024
    Classification Date
    April 23, 2024
    Address
    1074 Arion Cir Ste 116, N/A, San Antonio, TX, 78216-3085, United States

    Description

    LightStrike Blackout Curtains, Part numbers; 610-00008, 610-00009, 610-00019, 610-00020, and 610-00024, used with the LightStrike Germ-Zapping Robots Models: PXUV4D, PXUV5D, LSMUV6-FT, or LSMUV6-SL, for whole room microbial reduction.

    Reason

    Blackout curtains are no longer recommended as a protective barrier against UV/Ozone exposure to a bystander standing in the same room, but on the other side of the curtain from where a microbial reduction device UV cycle is taking place. Bystanders in the room during the cycle may experience temporary skin reddening, feeling of sand in eyes, nausea, headache, and/or mucous membrane irritation.

    Code Info

    Robot UDI-DIs: 00814122020033, 00814122020064, 00814122020125, 00814122020132. All serial numbers.

    Distribution

    US Nationwide distribution in the states of AR, AZ, CA, CO, FL, GA, HI, ID, IL, KY, LA, MI, MN, MO, NC, ND, NV, OH, OK, OR, TN, UT, WA, WV, WY.

    Quantity

    377