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U.S. Department of Health and Human Services

Class 2 Device Recall Walgreens Vital Health Rechargeable Toothbrush

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  Class 2 Device Recall Walgreens Vital Health Rechargeable Toothbrush see related information
Date Initiated by Firm January 14, 2011
Date Posted March 18, 2011
Recall Status1 Terminated 3 on December 16, 2012
Recall Number Z-1724-2011
Recall Event ID 57674
Product Classification Toothbrush, powered - Product Code JEQ
Product W Vital Health Pulsating Clean Rechargeable Toothbrush; Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015-4616, Made in China;

The toothbrush was sold with a single head and with three heads:
a) Rechargeable Power Toothbrush - Model Number 565222, UPC 0 49022 35396 1;
b) Rechargeable Power Toothbrush with 3 Replacement Heads: Model Number WIC 472641, UPC 0 49022 49612 5;

Intended to remove adherent plaque and food debris from the teeth to reduce tooth decay.
Code Information Item 565222, UPC: 0-49022-35396-1, lot 08/10;  Item 472641, UPC: 0-49022-49612-5, lot 08/10   
Recalling Firm/
Manufacturer		 Brushpoint Innovations, Inc.
2189 King Road
King City Canada Ontario
For Additional Information Contact Mr. Paul Cira
905-944-1000
Manufacturer Reason
for Recall		 The power toothbrush may make a loud noise and the battery cap becomes separated from the main body of the toothbrush. The battery cap can become a projectile that could cause potential injury if it comes in contact with the body.
FDA Determined
Cause 2		 Device Design
Action The firm, BrushPoint Innovations, sent a email dated January 7, 2011 notifying their customers of the recall. The email described the product, problem and actions to be taken. The customers were instructed to pull and quarantine the toothbrushes due to potential product quality concerns, and hold their stocks until January 14, 2011, call in the number of toothbrushes quarantined, and then return them to the Walgreen distribution centers. A stop sale was placed on the affected item numbers in their cash register scanners. If you have any questions, call 905-833-5122 or 905-944-1000.
Quantity in Commerce 8,100 units
Distribution 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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