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U.S. Department of Health and Human Services

Class 2 Device Recall Homedics PowerDent Model HD30

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  Class 2 Device Recall Homedics PowerDent Model HD30 see related information
Date Initiated by Firm February 16, 2005
Date Posted March 08, 2005
Recall Status1 Terminated 3 on August 18, 2005
Recall Number Z-0575-05
Recall Event ID 31175
Product Classification Toothbrush, Powered - Product Code JEQ
Product Homedics PowerDent battery powered toothbrush, Model HD-30, individually packaged; HoMedics, Inc., 3000 Pontiac Trail, Commerce Township, MI 48390, Made in China; UPC 31262-00789, Deals Nothing Over A Dollar SKU #100608494

The individually packaged toothbrushes are packaged 49 per case labeled as Decent Trading Adult Battery Operated Toothbrush Model #HD-30, Quantity: 49 pcs, Colour: Blue/Green, Made in China C/No 884
Code Information Deals Nothing Over A Dollar SKU #100608494,  all lots distributed by Deals Nothing Over A Dollar and Save-A-Lot stores between 10/22/04 and 2/3/05.
Recalling Firm/
Manufacturer		 Deals Nothing Over A Dollar
100 Corp Office Drive
Earth City MO 63045
For Additional Information Contact Ms. Barbara Campbell
314-264-7833
Manufacturer Reason
for Recall		 A defective seal allows water into the handle of the toothbrush via the bristles, and rusty water seeps back out of the toothbrush around the bristles.
FDA Determined
Cause 2		 Other
Action Deals Nothing Over A Dollar sent e-mails to the retail store on 2/16/05 indicating that the rotary brush from HoMedics has been recalled, and requesting that all product of SKU 100608494, HoMedics Rotary Brush, be pulled from the shelves and held pending disposal instructions.
Quantity in Commerce 10,535 toothbrushes
Distribution The product was distributed to Deals Nothing Over A Dollar and Save-A-Lot retail stores in Alabama, Arkansas, California, Colorado, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Mississippi, Missouri, North Carolina, Ohio, Oklahoma, South Carolina, Tennessee, Texas, Wisconsin and Wyoming.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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