Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0246-2022Class II

The product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with...

Max Lux Corp / initiated 2021-10-26 / Open, Classified

MAX LUX CORP began a recall of 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... on . FDA classified it as Class II and gives the reason as "Excessive ultraviolet-C radiation". As of , the recall status on record is Open, Classified.

Recall record

Recall number
Z-0246-2022
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Max Lux Corp
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.
Product code
RHP Uv Lamp, Germicidal
Reason for recall
Excessive ultraviolet-C radiation
FDA root cause
Radiation Control for Health and Safety Act
Quantity in commerce
9900 units
Distribution
US Nationwide Distribution
Product codes and lots
Safe-T Lite

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0246-2022
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0246-2022Class IIOngoingFDA Mandated