Z-1615-2024 Class II Ongoing
FDA device recall Z-1615-2024 was initiated by XENEX Disinfection Services Inc. on March 18, 2024 and is designated Class II. 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 redu… The recall status is ongoing. Affected quantity: 377.
Recall Details
- Product Type
- Devices
- Report Date
- May 1, 2024
- Initiation Date
- March 18, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 377
Product 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 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 Pattern
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.
Code Information
Robot UDI-DIs: 00814122020033, 00814122020064, 00814122020125, 00814122020132. All serial numbers.