Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall LightStrike Blackout Curtains

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall LightStrike Blackout Curtains see related information
Date Initiated by Firm March 18, 2024
Date Posted April 23, 2024
Recall Status1 Open3, Classified
Recall Number Z-1615-2024
Recall Event ID 94258
Product Classification Whole room microbial reduction device - Product Code QXJ
Product 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.
Code Information Robot UDI-DIs: 00814122020033, 00814122020064, 00814122020125, 00814122020132. All serial numbers.
Recalling Firm/
Manufacturer		 XENEX Disinfection Services Inc.
1074 Arion Cir Ste 116
San Antonio TX 78216-3085
For Additional Information Contact
210-489-0227
Manufacturer 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.
FDA Determined
Cause 2		 Device Design
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.
Quantity in Commerce 377
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
-
-