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U.S. Department of Health and Human Services

Class 2 Device Recall One Touch SafeTLite UV Wand

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 Class 2 Device Recall One Touch SafeTLite UV Wandsee related information
Date Initiated by FirmOctober 26, 2021
Create DateJanuary 05, 2022
Recall Status1 Open3, Classified
Recall NumberZ-0246-2022
Recall Event ID 89050
Product Classification Uv lamp, germicidal - Product Code RHP
ProductThe 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 with an intended use of disinfecting surfaces.
Code Information Safe-T Lite
FEI Number 3017032819
Recalling Firm/
Manufacturer		 MAX LUX CORP
03e 01 01 Yangxi Indust
Ry Zone
Yangjiangyangjiang China
Manufacturer Reason
for Recall		Excessive ultraviolet-C radiation
FDA Determined
Cause 2		Radiation Control for Health and Safety Act
Quantity in Commerce9900 units
DistributionUS Nationwide Distribution
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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