FDA recall Z-0246-2022

MAX LUX CORP · Class II · device

Product

The product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm range with an intended use of disinfecting surfaces.

Reason for recall

Excessive ultraviolet-C radiation

Distribution

US Nationwide Distribution

Key facts

Status
Ongoing
Initiation date
2021-10-26
Report date
2021-12-08
Voluntary/Mandated
FDA Mandated
Location
Yangjiangyangjiang, China

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0246-2022