Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0660-2020 — 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 procedur

U.S. FDA — Device Enforcement · United States · 2019-01-18 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0660-2020
Date of alert: 2019-01-18
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Bellus Medical
Product category: device
Product type: Devices

Reported risk: Cosmetic Kit was packaged with a mislabel medical product.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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