LightStrike Blackout Curtains Recalled Due to Inadequate UV and Ozone Protection
XENEX LightStrike Blackout Curtains are recalled due to inadequate protection against UV and ozone exposure. Bystanders in rooms during device operation may experience temporary skin reddening, eye irritation, nausea, and headache.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall. The blackout curtains failed to provide adequate protection against UV and ozone exposure, creating a risk of temporary skin reddening, eye irritation, nausea, and headache. No illnesses or injuries have been reported. Per the severity rubric, risk-of-harm products without confirmed injury are rated High.
Plain-English summary
LightStrike Blackout Curtains (part numbers 610-00008, 610-00009, 610-00019, 610-00020, and 610-00024) used with LightStrike Germ-Zapping Robot models PXUV4D, PXUV5D, LSMUV6-FT, and LSMUV6-SL are being recalled by manufacturer XENEX Disinfection Services Inc. These curtains, intended for whole-room microbial reduction, are no longer recommended as a protective barrier against UV and ozone exposure for bystanders in the same room during device operation.
Bystanders present in the room during a microbial reduction cycle may experience temporary skin reddening, a feeling of sand in the eyes, nausea, headache, and mucous membrane irritation. The recall involves 377 units distributed nationwide.
The recalled product
- 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.
- Manufacturer
- XENEX Disinfection Services Inc.
- Affected units
- 377
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Robot UDI-DIs: 00814122020033
- 00814122020064
- 00814122020125
- 00814122020132. All serial numbers.
Distribution
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