Device product
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.
Z-0660-2020
Product summary
- Firm
- Bellus Medical
- Event
- Event 84154
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6007
- Official record key
device-enforcement:Z-0660-2020
Official wording
Reason: Cosmetic Kit was packaged with a mislabel medical product.
Code information: Bellus Lot 16053 list on the SKINFUSE LIFT HG tube within the SKINFUSE Rescue Calming Complex Kit
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Labeling or packaging
mislabel