Recall Z-0660-2020 ยท QAI Powered Microneedle Device
Bellus Medical
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.
| Date | Jan 18, 2019 |
| Status | Terminated |
| Reason | Cosmetic Kit was packaged with a mislabel medical product. |
| 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 an |
| Quantity | 6007 |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.