FDA Enforcement Class II Ongoing

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.

Recall: Z-1661-2022 · Reported September 14, 2022

Enforcement

Recall Number
Z-1661-2022
Event ID
90799
Classification
Class II
Status
Ongoing
Product Type
Devices
Firm
MERCHSOURCE LLC
Voluntary / Mandated
FDA Mandated
Initial Notification
Letter
Report Date
September 14, 2022
Initiation Date
August 1, 2022
Classification Date
September 6, 2022
Address
7755 Irvine Center Dr, N/A, Irvine, CA, 92618-2906, United States

Description

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.

Reason

Excessive ultraviolet-C radiation

Code Info

model no. 1013622

Distribution

US Nationwide Distribution

Quantity

N/A