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Class 2 Device Recall SmileFrida the ToothHugger |
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Date Initiated by Firm |
January 27, 2020 |
Date Posted |
January 30, 2020 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1103-2020 |
Recall Event ID |
84707 |
Product Classification |
Toothbrush, manual - Product Code EFW
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Product |
fridababy SmileFrida the TOOTHHUGGER 18+ months Triple Angle Brush Cleans All Sides at Once |
Code Information |
All Lots |
Recalling Firm/ Manufacturer |
Fridababy LLC 82 Ne 26th St Ste 101 Miami FL 33137-4406
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For Additional Information Contact |
Customer Service 305-673-7535
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Manufacturer Reason for Recall |
FridaBaby has been made aware through customer reports that the product is being used outside of the labeled directions. Specifically, repeated chewing or biting on the SmileFrida, the ToothHugger has caused deterioration in the outer layer of the brush and in very rare occasions, may cause the hard plastic brush head to break, exposing a small metal piece welded inside the brush head.
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FDA Determined Cause 2 |
Use error |
Action |
Consignees will be notified via email with recall letter. The letter identifies affected product, stated reason for recall, and request to inspect the product for evidence of misuse and discard if necessary. If product has not been used, the consignee is reminded to follow the product labeling. A response to the recall notification via email is requested. |
Quantity in Commerce |
480,144 |
Distribution |
Nationwide. International distribution to Canada, Mexico, Nicaragua, Dominican Republic, Honduras, Chile, Peru, Qatar.
No US governmental consignees. |
Total Product Life Cycle |
TPLC Device Report
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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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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