Z-0457-2023 Class II Ongoing
FDA device recall Z-0457-2023 was initiated by PHONESOAP on August 30, 2022 and is designated Class II. Reason for recall: Excessive ultraviolet-C radiation The recall status is ongoing. Affected quantity: 6,700 systems.
Recall Details
- Product Type
- Devices
- Report Date
- December 28, 2022
- Initiation Date
- August 30, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 6,700 systems
Product 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 for Recall
Excessive ultraviolet-C radiation
Distribution Pattern
US Nationwide Distribution
Code Information
SurfaceSoap UV Disinfecting Wand