Z-0819-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 7, 2018
- Initiation Date
- December 4, 2017
- Termination Date
- May 28, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 524 units
Product Description
Ultra Renew
Reason for Recall
Distribution of medical devices with unapproved green LED light used to treat hyperpigmentation
Distribution Pattern
US Nationwide
Code Information
none