The Recall Desk

FDA (Devices) recall action 75048

New Star Lasers, Inc. recalled 3 products on 2016-10-12

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2016-10-12
Critical
0
Units
22

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–3 of 3

  • ModerateFDA (Devices)··2016-10-12

    New Star Lasers Recalls ReNew Dermatology Devices for Labeling Errors

    New Star Lasers is recalling five ReNew laser systems because customers were not notified when promotional material was revised to remove outside-use indications.

    Product
    ReNew (a.k.a. Trio) Dermatology: for use in dermatology for incision, excision, ablation and vaporization with hemostasis of soft tissue; for use in the treatment of fine lines and wrinkles; for treatment of back acne and atrophic acne scars; for treatment of reflux of the
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2016-10-12

    New Star Lasers Recalls CT3Plus and CT3PZ Systems for Labeling Issues

    New Star Lasers is recalling 91 CT3Plus and CT3PZ laser systems because customers were not notified when promotional labeling was revised to remove outside-use indications.

    Product
    CT3Plus (a.k.a. CT3PZ); Catalog number: 7300-0038/ 7300-0038-1. Dermatology: For use in dermatology for incision, excision, ablation, and vaporization with hemostasis of soft tissue; For treatment of fine lines and wrinkles; For mild to moderate inflammatory acne vulgaris
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2016-10-12

    New Star Lasers Recalls VariaBreeze Systems Due to Labeling Notification Failure

    New Star Lasers is recalling 17 VariaBreeze laser systems because customers were not notified when promotional material was revised to remove outside-use indications.

    Product
    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
    Category
    Distribution
    0 states