Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall SurfaceSoap UV Disinfecting Wand

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall SurfaceSoap UV Disinfecting Wand see related information
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
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
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
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.
-
-