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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm April 09, 2003
Date Posted May 20, 2003
Recall Status1 Terminated 3 on October 26, 2004
Recall Number Z-0847-03
Recall Event ID 26147
Product Classification Toothbrush, Powered - Product Code JEQ
Product ''Hello Kitty'', Plaque Removing Toothbrush, Model HK70W. Powered toothbrush.
Code Information Gimelli No: 7625.006; Emerson #: HK70W.
Recalling Firm/
Manufacturer		 Emerson Radio Corp.
9 Entin Rd
Parsippany NJ 070540430
For Additional Information Contact Elizabeth J. Calianese
973-428-2026
Manufacturer Reason
for Recall		 Powered toothbrushes are exploding due to gas build-up.
FDA Determined
Cause 2		 Other
Action Telephone calls were initiated on 4/9/2003 to Emerson''s customers by their sales personnel. Instructions were to remove from the store shelves and return to Emerson.
Quantity in Commerce 48,830
Distribution Product was distributed nationwide to primarily Target stores, Toys R Us and Kids R Us as well as a small number of retail establishments. NASCAR Model NC70 was only distributed to Target Stores.
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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