VariaBreeze recalled over mold contamination

Recall date

September 19, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

New Star Lasers, Inc. recalls VariaBreeze; Catalog number: 7300-0035-2. Podiatry: ablation, vaporization, incision, excision, and coagulation of soft…

Recall number

Z-2915-2016

FDA classification

Class II

Brand / firm

New Star Lasers, Inc.

Sold / distributed

US distribution only.

Why it was recalled

FDA inspection found that customers who had received devices with promotional material with outside use indications were not notified when labeling was revised to remove these indications.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

VariaBreeze; Catalog number: 7300-0035-2. Podiatry: ablation, vaporization, incision, excision, and coagulation of soft tissue including matrixectomy, periungal and subungal warts, plantar warts, radical nail excision, and neuromas. The temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.)