Bellus Medical product recalled over labeling errors

Recall date

January 18, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Bellus Medical recalls SKINFUSE Resuce Calming Complex Kit containing: SKINFUSE LIFT HG - Product Usage: The SKINFUSE Rescue Calming Complex i…

Recall number

Z-0660-2020

FDA classification

Class II

Brand / firm

Bellus Medical

Sold / distributed

US Nationwide distribution.

Why it was recalled

Cosmetic Kit was packaged with a mislabel medical product.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.