BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated March 18, 2024

    Recall

    Recall Number
    Z-1615-2024
    Event Number
    94258
    Firm
    XENEX Disinfection Services Inc.
    FEI Number
    3014531752
    Product Code
    QXJ
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    March 18, 2024
    Posted
    April 23, 2024
    Address
    1074 Arion Cir, Ste 116, San Antonio, TX, 78216-3085

    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.

    Action

    On 3/18/24, correction notices were emailed to customers informing them of the following: 1) Blackout Curtains can continue to be used to block nuisance light coming from an unoccupied room/area where a UV cycle is being executed. It is not necessary to return curtains. 2) If your practice is to use this Blackout Curtain as a protective barrier, discontinue the use in occupied spaces. 3) If you may have further distributed this product, please identify your customers, and notify them at once of this product field correction or provide us with their contact information so the firm can reach out to them. Complete and return the response form. If you have any questions, call the firm at (830) 832-4299 between the hours of 8:00AM and 5:00PM CST Monday through Friday.

    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