Z-0660-2020 Class II Terminated
FDA device recall Z-0660-2020 was initiated by Bellus Medical on January 18, 2019 and is designated Class II. Reason for recall: Cosmetic Kit was packaged with a mislabel medical product. The recall status is terminated (terminated March 5, 2021). Affected quantity: 6007.
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