Class 2 Device Recall Oral B

• Date Initiated by Firm: October 27, 2004
• Date Posted: November 06, 2004
• Recall Status: Terminated on November 21, 2005
• Recall Number: Z-0185-05
• Recall Event ID: 30266
• Product Classification: Toothbrush, Powered - Product Code JEQ
• Product: CrossAction Power Brushead Refills, Medium 2-Count Pack NDC: 0-69055-82448-1
• 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: 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.