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U.S. Department of Health and Human Services

Class 2 Device Recall TopCare Clifford THE BIG RED DOG power toothbrush

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  Class 2 Device Recall TopCare Clifford THE BIG RED DOG power toothbrush see related information
Date Initiated by Firm December 18, 2013
Date Posted January 17, 2014
Recall Status1 Terminated 3 on August 20, 2015
Recall Number Z-0781-2014
Recall Event ID 67123
Product Classification Toothbrush, powered - Product Code JEQ
Product TopCare Clifford THE BIG RED DOG power toothbrush for kids!
Code Information UPC 071031069496, all lots
Recalling Firm/
Manufacturer		 Ranir Corporation
4701 East Paris Ave SE
Grand Rapids MI 49512-5353
For Additional Information Contact Denise Phillips
616-698-8880
Manufacturer Reason
for Recall		 Ranir, LLC is recalling all lots of Up & Up brand Kid's Power Toothbrush and TopCare brand Clifford Kids Power Toothbrush because the tufted disk may become detached from the power brush handle. If the tuft retention disk detaches from the handle, it is a potential choking hazard for children three years old and younger.
FDA Determined
Cause 2		 Device Design
Action Ranir, LLC phoned their two direct accounts notifying them of this recall on December 12, 2013. On December 18, 2013, Ranir, LLC sent an URGENT: MEDICAL DEVICE RECALL notification letter was sent to their direct accounts. The notification stated the affected product, issue, and instructions for responding to the notification, including instructions for return of the affected product. Questions are directed to Paula Bojsen (616)698-8880.
Quantity in Commerce 601,616 total
Distribution Distributed in MN and IL.
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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