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U.S. Department of Health and Human Services

Class 2 Device Recall Germ Terminator Toothbrush Steam Sterilization

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  Class 2 Device Recall Germ Terminator Toothbrush Steam Sterilization see related information
Date Initiated by Firm April 05, 2016
Create Date June 23, 2016
Recall Status1 Terminated 3 on November 22, 2016
Recall Number Z-2047-2016
Recall Event ID 74015
510(K)Number K021258  
Product Classification Unit, ultraviolet sanitation/sterilization (for toothbrushes), sterile - Product Code MCF
Product Germ Terminator, Toothbrush Steam Sterilization for Oral Health. Model GT100. The Germ Terminator uses steam heat to sanitize two manual toothbrushes or two toothbrush heads. Water is poured into a reservoir in the device's housing. The steam cycle is followed by a drying cycle.
Code Information Model GT100
Recalling Firm/
Manufacturer		 Ceg Enterprises Llc
8096 Excelsior Blvd
Hopkins MN 55343-3415
For Additional Information Contact Keith Carpenter
612-337-1821
Manufacturer Reason
for Recall		 CEG Enterprises, LLC is recalling Germ Terminator Toothbrush Sanitizer GT100 due to the following issues: UL label believed to be not genuine; discoloration of power cords (could indicate some degradation); reports of excessive heat.
FDA Determined
Cause 2		 Unknown/Undetermined by firm
Action CEG Enterprises sent an Urgent Germ Terminator Toothbrush Sanitizer GT100 Recall letter dated April 19, 2016, via UPS and email to all affected customers. The letter identified the affected product, the reason for recall, stated to quarantine product, and to return all remaining product. The letter also instructed that Tuesday Morning retail stores post the recall notification letter on the retail shelves where the product was offered for sale, as well as on their website. Consumers are encouraged to return the device to a Tuesday Morning retail store. Questions can be directed to 612-337-1821
Quantity in Commerce 100,548 units
Distribution Nationwide Distribution through Tuesday Morning retail stores.
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.
510(K) Database 510(K)s with Product Code = MCF and Original Applicant = GERM TERMINATOR CORPORATION
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