Z-0348-2020 Class II
Recall Details
- Product Type
- Devices
- Report Date
- November 20, 2019
- Initiation Date
- October 18, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 1257 units
Product Description
Energy FX: a) original Aluminum (100-3A) b) sleek (adult and kid & pet) (100-3B)
Reason for Recall
FDA determined that marketing claims surrounding product rendered product a medical device which was adulterated and misbranded.
Distribution Pattern
US, Puerto Rico, U.S. Virgin Islands, Canada, Mexico, Australia, PHILIPPINES, Greece, United Kingdom, Israel, Nigeria, Hungary, United Arab Emirates
Code Information
All product distributed between November 7, 2017 to September 4, 2019