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U.S. Department of Health and Human Services

Class 2 Device Recall Skinfuse Rescue Calming Complex/Lift HG

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  Class 2 Device Recall Skinfuse Rescue Calming Complex/Lift HG see related information
Date Initiated by Firm January 18, 2019
Create Date December 09, 2019
Recall Status1 Terminated 3 on March 05, 2021
Recall Number Z-0660-2020
Recall Event ID 84154
Product Classification Powered microneedle device - Product Code QAI
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.
Code Information Bellus Lot 16053 list on the SKINFUSE LIFT HG tube within the SKINFUSE Rescue Calming Complex Kit
Recalling Firm/
Manufacturer		 Bellus Medical
5005 LBJ Freeway, Ste 370
Dallas TX 75244-6144
For Additional Information Contact Jennifer Block
888-372-3982
Manufacturer Reason
for Recall		 Cosmetic Kit was packaged with a mislabel medical product.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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