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.
FDA Recall Z-0660-2020 · Posted None
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Recalling FirmBellus Medical
Recall StatusTerminated
Product CodeQAI
Date Initiated2019-01-18
Date Terminated2021-03-05
Product Quantity6007
Reason for Recall
Cosmetic Kit was packaged with a mislabel medical product.
Firm 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.
Root Cause
Mixed-up of materials/components
Distribution Pattern
US Nationwide distribution.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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