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U.S. Department of Health and Human Services

Class 2 Device Recall SmileFrida the ToothHugger

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 Class 2 Device Recall SmileFrida the ToothHuggersee related information
Date Initiated by FirmJanuary 27, 2020
Date PostedJanuary 30, 2020
Recall Status1 Open3, Classified
Recall NumberZ-1103-2020
Recall Event ID 84707
Product Classification Toothbrush, manual - Product Code EFW
Productfridababy SmileFrida the TOOTHHUGGER 18+ months Triple Angle Brush Cleans All Sides at Once
Code Information All Lots
FEI Number 3005630901
Recalling Firm/
Manufacturer		 Fridababy LLC
82 Ne 26th St Ste 101
Miami FL 33137-4406
For Additional Information ContactCustomer Service
305-673-7535
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.
FDA Determined
Cause 2		Use error
ActionConsignees 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 Commerce480,144
DistributionNationwide. International distribution to Canada, Mexico, Nicaragua, Dominican Republic, Honduras, Chile, Peru, Qatar. No US governmental consignees.
Total Product Life CycleTPLC 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 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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