FDA recall Z-0660-2020

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.

Reason for recall

Cosmetic Kit was packaged with a mislabel medical product.

Distribution

US Nationwide distribution.

Key facts

Status

Terminated

Initiation date

2019-01-18

Report date

2019-12-18

Termination date

2021-03-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Dallas, TX, United States

Primary source

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