FDA-Device2019-12-18Class II

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.

Bellus Medical
Hazard

Cosmetic Kit was packaged with a mislabel medical product.

Sold states
US Nationwide distribution.
Affected count
6007
Manufactured in
5005 LBJ Freeway, Ste 370, N/A, Dallas, TX, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0660-2020

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