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U.S. Department of Health and Human Services

Class 2 Device Recall Colgate 360 Replaceable Head Battery Powered Toothbrush Soft

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  Class 2 Device Recall Colgate 360 Replaceable Head Battery Powered Toothbrush Soft see related information
Date Initiated by Firm March 23, 2012
Date Posted June 27, 2012
Recall Status1 Terminated 3 on June 19, 2013
Recall Number Z-1873-2012
Recall Event ID 61670
Product Classification Toothbrush, ionic, battery-powered - Product Code MMD
Product Colgate 360 Replaceable Head Battery Powered Toothbrush Soft UPC 03500068747
Dist. by
Colgate-Palmolive Co.
New York, NY 10022
Made in China.

For teeth cleansing.
Code Information All products
Recalling Firm/
Colgate Palmolive Company
191 E Hanover Ave
Morristown NJ 07960-3151
For Additional Information Contact Mr. Charles P. Ireland
Manufacturer Reason
for Recall
Brush battery cap was forcibly blown off at the end of the brush handle.
FDA Determined
Cause 2
Nonconforming Material/Component
Action Colgate-Palmolive Company sent an "URGENT: MEDICAL DEVICE RECALL" letter dated March 22, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter requests the termination of sale and segregation of the affected product for return. Contact your Colgate-Palmolive representative to coordinate return of the affected product or if you have any questions concerning this matter.
Quantity in Commerce 280,044 units (Total)
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.