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U.S. Department of Health and Human Services

Class 2 Device Recall Oral B

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  Class 2 Device Recall Oral B see related information
Date Initiated by Firm October 27, 2004
Date Posted November 06, 2004
Recall Status1 Terminated 3 on November 21, 2005
Recall Number Z-0182-05
Recall Event ID 30266
Product Classification Toothbrush, Powered - Product Code JEQ
Product Oral-B CrossAction PowerMAX Rechargeable Toothbrush, , Soft
4 Accent Colors: Blue, Pink, Green. Purple
NDC 0-69055-83293-6
Code Information ALL
Recalling Firm/
Manufacturer
Gillette Research Institute
37 A St
Needham MA 02494-2806
For Additional Information Contact Kevin Loftus
617-421-7880
Manufacturer Reason
for Recall
Brushhead may unlatch from the power handle
FDA Determined
Cause 2
Other
Action Gillette issued recall notification letters on 10/27/04 via Fed''X to Distributors and retail accounts requesting the removal and return of the devices. In addtion a Consumer letter issued 10/27/04 to provide information to the special needs and others that they are offering a replacement product for those of special needs. Gillette will post the consumer notifcation on the Gillette (Gillette.com) and Oral-B (Oral-B.com) websites.
Distribution Nationwide
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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