Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0457-2023Class II

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

Phonesoap / initiated 2022-08-30 / Open, Classified

PHONESOAP began a recall of The product is a handheld ultraviolet-C germicidal wand and contains 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-0457-2023
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Phonesoap
Product
The product is a handheld ultraviolet-C germicidal wand and contains narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm range.
Product code
RHP Uv Lamp, Germicidal
Reason for recall
Excessive ultraviolet-C radiation
FDA root cause
Radiation Control for Health and Safety Act
Action
PhoneSoap LLC (PhoneSoap) will send the notification letter by certified mail to all purchasers, dealers, distributors and any known subsequent transferees. As part of the Notification Letter, PhoneSoap will direct the purchasers, dealers, distributors and any known subsequent transferees to return the product to PhoneSoap using an enclosed, prepaid mailing label within 6 months of receipt of the letter. PhoneSoap will replace all returned SurfaceSoap UV devices with its closed-system PhoneSoap Go, free of charge.
Quantity in commerce
6,700 systems
Distribution
US Nationwide Distribution
Product codes and lots
SurfaceSoap UV Disinfecting Wand

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0457-2023
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0457-2023Class IIOngoingFDA Mandated