FDA Recall
Completed
Energy FX: a) original Aluminum (100-3A) b) sleek (adult and kid & pet) (100-3B)
Recall: Z-0348-2020
·
Initiated October 18, 2019
Recall
- Recall Number
- Z-0348-2020
- Event Number
- 84117
- Firm
- Basic Reset Inc.
- FEI Number
- 3007197806
- Product Code
- N/A
- Status
- Completed
- Root Cause
- No Marketing Application
- Initiated
- October 18, 2019
- Address
- 260 W Main St, Ste 103, Hendersonville, TN, 37075-7316
Description
Energy FX: a) original Aluminum (100-3A) b) sleek (adult and kid & pet) (100-3B)
Reason
FDA determined that marketing claims surrounding product rendered product a medical device which was adulterated and misbranded.
Action
The firm initiated the recall on 09/23/2019 by email and followed with a second letter on 10/18/2019. The letter requests the consignee discard/destroy the product.
Distribution
US, Puerto Rico, U.S. Virgin Islands, Canada, Mexico, Australia, PHILIPPINES, Greece, United Kingdom, Israel, Nigeria, Hungary, United Arab Emirates
Quantity
1257 units