Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1661-2022Class II

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

Merchsource LLC / initiated 2022-08-01 / Open, Classified

MERCHSOURCE LLC 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-1661-2022
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Merchsource LLC
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.
Product code
RHP Uv Lamp, Germicidal
Reason for recall
Excessive ultraviolet-C radiation
FDA root cause
Radiation Control for Health and Safety Act
Action
MerchSource issued a Safety Recall letter to affected customers dated August, 2022. Customers were instructed to immediately terminate sale of the Sharper Image UV Sanitizing Portable Wand MerchSource will coordinate with you for the return or destruction of the product. MerchSource will provide a refund in the full amount of the purchase price to all of its customers affected.
Distribution
US Nationwide Distribution
Product codes and lots
model no. 1013622

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1661-2022
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1661-2022Class IIOngoingFDA Mandated