Recall Z-0660-2020— Bellus Medical
Class II · Terminated
Class II FDA medical device recall by Bellus Medical, initiated 2019-01-18, terminated 2021-03-05. FDA's recall record names no specific 510(k) clearance for this event. 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: Cosmetic Kit was packaged with a mislabel medical product..
- Recalling firm
- Bellus Medical
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-01-18
- Terminated
- 2021-03-05
- Firm location
- Dallas, TX, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.