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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the specific issue is a failure to notify customers of labeling revisions regarding promotional indications, which constitutes a minor labeling error without reported injuries or illnesses.
Plain-English summary
New Star Lasers, Inc. is recalling 44 CT3Plus systems and 47 CT3PZ systems. These medical devices are used in dermatology and podiatry for procedures such as incision, excision, ablation, and vaporization of soft tissue, as well as for treating fine lines, wrinkles, and acne.
The recall was initiated after an FDA inspection found that customers who had received devices with promotional material containing outside-use indications were not notified when the labeling was revised to remove these indications. The devices were distributed only in the United States.
Customers who possess these specific serial numbers should contact New Star Lasers, Inc. for further instructions on how to resolve the labeling discrepancy. The recall number is Z-2914-2016.
The recalled product
- 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…
- Manufacturer
- New Star Lasers, Inc.
- Category
- Medical Device — Laser Systems
- Hazard
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 recalled by New Star Lasers, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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