Reported Oct 12, 2016 · Terminated
VariaBreeze; Catalog number: 7300-0035-2. Podiatry: ablation, vaporization, incision, excision, and coagulation of soft…
New Star Lasers, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: New Star Lasers, Inc. · 9085 Foothills Blvd · Roseville, CA · 95747-7130
Is this the product you have?
- VariaBreeze
- Catalog number7300-0035-2
- Podiatryablation, 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.)
- Lot codes and dates
- Serial numbers
XSB02-VBAESB01AHSF02AHSF04AHSF05AHSF06AHSF07AHSF08AHTE01AHSF03AHTF01AHTF02AHTH01AHTM02AHTM01AHTS01AHTS03
- Serial numbers
- Amount recalled
- 17 systems
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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