Z-0660-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 18, 2019
- Initiation Date
- January 18, 2019
- Termination Date
- March 5, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6007
Product Description
SKINFUSE Resuce Calming Complex Kit containing: SKINFUSE LIFT HG - Product Usage: The SKINFUSE Rescue Calming Complex is intend to be used to soothe and calm skin (cosmetic). The SKINFUSE LIFT HG is a hydrogel wound dressing to protect against abrasion and friction during the microneedling procedure.
Reason for Recall
Cosmetic Kit was packaged with a mislabel medical product.
Distribution Pattern
US Nationwide distribution.
Code Information
Bellus Lot 16053 list on the SKINFUSE LIFT HG tube within the SKINFUSE Rescue Calming Complex Kit