| Class 2 Device Recall SurfaceSoap UV Disinfecting Wand | |
Date Initiated by Firm | August 30, 2022 |
Date Posted | December 16, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0457-2023 |
Recall Event ID |
91221 |
Product Classification |
Uv lamp, germicidal - Product Code RHP
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Product | 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. |
Code Information |
SurfaceSoap UV Disinfecting Wand |
Recalling Firm/ Manufacturer |
PHONESOAP 1837 S East Bay Blvd Ste 201 Provo UT 84606-5530
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Manufacturer Reason for Recall | Excessive ultraviolet-C radiation |
FDA Determined Cause 2 | Radiation Control for Health and Safety Act |
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. |
Quantity in Commerce | 6,700 systems |
Distribution | US Nationwide Distribution |
Total Product Life Cycle | TPLC Device Report |
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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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