FDA, Safety Warning Against Safe-T-Lite UV WAND

The U.S. Food and Drug Administration (FDA) is warning consumers about the potential risk of injury associated with the use of the Safe-T-Lite UV WAND, manufactured by Max-Lux Corporation Limited. Use of Max-Lux Safe-T-Lite UV WAND may expose the user or any nearby person to unsafe levels of ultraviolet-C (UV-C) radiation and may cause injury to the skin, eyes, or both after a few seconds of use.

The FDA is aware that consumers may use the Max-Lux Safe-T-Lite UV WAND to try to disinfect surfaces and kill germs in the home or similar spaces. The FDA recommends that consumers consider using safer alternative disinfection methods, such as general purpose disinfectants.

Recommendations for Consumers

• Do not use the Max-Lux Safe-T-Lite UV WAND. Consider using alternative disinfection methods, such as chemical cleaners to kill germs in the home or similar spaces.

• Be aware the Max-Lux Safe-T-Lite UV WAND emits unsafe levels of UV-C radiation and may cause injuries to the eyes or skin of a user or person nearby.

• Be aware the Max-Lux Safe-T-Lite UV WAND does not have adequate safety features to eliminate the risk of injury to the user or persons nearby from unsafe level of UV-C radiation.

• Read more about UV Lights and Lamps: Ultraviolet-C Radiation, Disinfection, and Coronavirus.

Product Description and Background

The Max-Lux Safe-T-Lite UV WAND is a handheld UV-C germicidal wand and is intended to emit UV-C radiation to disinfect surfaces.

The Max-Lux Safe-T-Lite UV WAND instructions for use instruct consumers to hold the product in hand for the duration of the disinfection process, 30 to 60 seconds. The product emits a level of radiation more than 3,000 times stronger than what is recommended by an international group of experts for an ultraviolet exposure limitExternal Link Disclaimer at a distance of about two inches. The user or any person near a Safe-T-Lite UV WAND may experience an injury to the skin (erythema), eyes (photokeratitis), or both after a few seconds of exposure.

FDA Actions

The FDA has issued a Notification of Defect Letter to Max-Lux Corporation Limited, providing notice that FDA had concluded, according to its regulations, that the Safe-T-Lite UV WAND has a defect.

The FDA will continue to monitor this issue and keep the public informed if significant new information becomes available.

Reporting Problems with Your Product

Manufacturers and anyone in the general public may use the Accidental Radiation Occurrence Report form to submit a report on any radiation incident or potentially hazardous event.

Health professionals and consumers can also report problems with medical products including serious reactions, product quality problems and product use errors. For more information about submitting a report, see Voluntary Reporting by Health Professionals or MedWatch Reporting by Consumers.

SOURCE :

https://www.fda.gov/medical-devices/safety-communications/risk-exposure-unsafe-levels-radiation-safe-t-lite-uv-wand-fda-safety-communication?utm_source=FDAFacebook