Exact FDA event identifier

Event 84154

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket: January 18, 2019
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Bellus Medical

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-0660-2020

Recall number: Z-0660-2020
Initiated: January 18, 2019
Classification: Class II
Status: Terminated
Recalling firm: Bellus Medical
Quantity: 6007

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

mislabel

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Mixed-up of materials/components

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Cosmetic Kit was packaged with a mislabel medical product.

Code information

Bellus Lot 16053 list on the SKINFUSE LIFT HG tube within the SKINFUSE Rescue Calming Complex Kit

Distribution pattern

US Nationwide distribution.