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.
This recall is currently active, issued April 23, 2024. It was issued by Xenex Disinfection Services Inc..
- Company
- Xenex Disinfection Services Inc.
- Recall Initiated
- March 18, 2024
- Posted
- April 23, 2024
- Recall Number
- Z-1615-2024
- Quantity
- 377
- Firm Location
- San Antonio, TX
- Official Source
- View on FDA website ↗
Reason for Recall
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.
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.
Lot / Code Info
Robot UDI-DIs: 00814122020033, 00814122020064, 00814122020125, 00814122020132. All serial numbers.
Root Cause
Device Design
Action Taken
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.