FDA Recall
Open, Classified
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.
Recall: Z-0457-2023
·
Initiated August 30, 2022
Recall
- Recall Number
- Z-0457-2023
- Event Number
- 91221
- Firm
- PHONESOAP
- FEI Number
- 3016746333
- Product Code
- RHP
- Status
- Open, Classified
- Root Cause
- Radiation Control for Health and Safety Act
- Initiated
- August 30, 2022
- Posted
- December 16, 2022
- Address
- 1837 S East Bay Blvd, Ste 201, Provo, UT, 84606-5530
Description
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.
Reason
Excessive ultraviolet-C radiation
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.
Distribution
US Nationwide Distribution
Quantity
6,700 systems