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U.S. Department of Health and Human Services

Class 2 Device Recall Wally's Ear Candles

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  Class 2 Device Recall Wally's Ear Candles see related information
Date Initiated by Firm February 17, 2010
Date Posted September 24, 2010
Recall Status1 Terminated 3 on March 28, 2011
Recall Number Z-2487-2010
Recall Event ID 56423
Product Ear Candles made from either Paraffin or Beeswax, in plain, herbal scented, or lavender scented varieties, manufactured by Wally's Natural Products, Auburn, CA.
Code Information All products are under recall
Recalling Firm/
Manufacturer		 Wally's Natural Products
11837 Kemper Rd Ste 5
Auburn CA 95603-9067
Manufacturer Reason
for Recall		 Product is an unapproved medical device. Use as directed may result in accidental damage to the eardrum, leading to injuries up to loss of hearing.
FDA Determined
Cause 2		 Other
Action The firm conducted communications via phone, mail and website, stating that they have stopped manufacturing and distributing ear candles, and asks consumers to return for a refund.
Quantity in Commerce Not Specified. All
Distribution Nationwide Distribution
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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