Events

Recall of CT3Plus

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by New Star Lasers, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    75048
  • Event Risk Class
    Class 2
  • Event Number
    Z-2914-2016
  • Event Initiated Date
    2016-09-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-12-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149186
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Powered laser surgical instrument - Product Code GEX
  • Reason
    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.
  • Action
    Letters sent on September 19, 2016 via US mail advised customers of the unapproved claims that may be in their literature and advised of the approved uses for each device.

Device

CT3Plus
  • Model / Serial
    Serial numbers CT3Plus:  4009 4023 ABB0271 4030 4016 ABB0900 ABC0363 BBC1457 ABB0862 ABD0757 ABD1363 ABE0101 ABE1258 BBE1875 ABC1193 BBG1209 ABH1818 ABC1067 ABK2803 ABM0371 ABM1206 ABP1160 ABS1067 ACA1652 ACA1790 ACA2139 ACC1485 ACD0843 ACC1158 ACA1333 ABB0388 SEM02 SEM07 ABB0423 ABE1663 4014 UHG01 UHM02 ABS1761 ABC0921 ABF0613 3045 ABM1410 ABC1252.  Serial numbers CT3PZ: ACA1011 ABD0501 UKH01-Z ADMS01 ADMS02 ADMS03 ADPA01 ADPA02 ABS1353-Z ADPD02 ADPD03 ADPD04 ADPD05 ADPD06 ADPE01 ADPE02 ABM1999 ADPE06 ADPE05 ADPG01 ABP1509 ADPH01 ADPH02 ADPH04 ADPH05 ADPH06 ADPH07 ADPE04 ADPK01 ADPK04 ADPK05 ADPK07 ADPM03 ADPP02 ADSB01 3023 4004 ACD1006 4002-Z ACD1621-Z ADSP01 UHK01-Z ADSS04 ADTE01 ADTG01 ABS1171-Z ADUE01.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US distribution only.
  • Product Description
    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; || For back acne and atrophic scarring, and; || For podiatry, (incision, excision, and coagulation of soft tissue), including. || matrixectomy, periungal and subungal warts, plantar warts, || radical nail excision, and neuromas
  • Manufacturer
    New Star Lasers, Inc.

Manufacturer

New Star Lasers, Inc.
  • Manufacturer Address
    New Star Lasers, Inc., 9085 Foothills Blvd, Roseville CA 95747-7130
  • Manufacturer Parent Company (2017)
    New Star Lasers Inc.
  • Source
    USFDA