Z-0660-2020Class II

SKINFUSE Resuce Calming Complex Kit containing: SKINFUSE LIFT HG -

Name: Z-0660-2020 SKINFUSE Resuce Calming Complex Kit containing: SKINFUSE LIFT HG -
Creator: Bellus Medical
Published: 2019-01-18
License: https://open.fda.gov/license/

Bellus Medical, LLC / initiated 2019-01-18 / Terminated / root cause: labeling and UDI

FDA source

Bellus Medical began a recall of 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... on 2019-01-18. FDA classified it as Class II and gives the reason as "Cosmetic Kit was packaged with a mislabel medical product". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0660-2020
Classification: Class II
Status: Terminated
Initiated: 2019-01-18
Posted: 2019-12-09
Terminated: 2021-03-05
Recalling firm: Bellus Medical, LLC
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.
Product code: QAI Powered Microneedle Device
Reason for recall: Cosmetic Kit was packaged with a mislabel medical product.
Root cause tag: labeling and UDI
FDA root cause: Mixed-up of materials/components
Action: On 01/18/2019, the firm notified customers (medical practices) via a telephone and/or email informing them of an incorrect labeling of product and for the physicians to return the product and to dispose of any open products. Affected products contained the Lot Number 16053. In addition, the firm send an "URGENT: Notification to Practice" letter via certified mail to customer and included an "URGENT: Notification to Patients" template letter that physicians were to used to notify their patients of the recall action. Customer were instructed to complete and return an enclosed response form and if there were any questions to contact the Director of Quality & Regulatory at Office Number 888.372.3983 or Direct Number 972.232.2899.
Quantity in commerce: 6007
Distribution: US Nationwide distribution.
Product codes and lots: Bellus Lot 16053 list on the SKINFUSE LIFT HG tube within the SKINFUSE Rescue Calming Complex Kit

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0660-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0660-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-18	2019-12-09

Product code QAI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)