Reported Oct 12, 2016 · Terminated
CT3Plus (a.k.a. CT3PZ); Catalog number: 7300-0038/ 7300-0038-1. Dermatology: For use in dermatology for incision,…
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?
- CT3Plus (a.k.a. CT3PZ)
- Catalog number7300-0038/ 7300-0038-1
- DermatologyFor 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
- Lot codes and dates
- Serial numbers CT3Plus
40094023ABB027140304016ABB0900ABC0363BBC1457ABB0862ABD0757ABD1363ABE0101ABE1258BBE1875ABC1193BBG1209ABH1818ABC1067ABK2803ABM0371ABM1206ABP1160ABS1067ACA1652ACA1790ACA2139ACC1485ACD0843ACC1158ACA1333ABB0388SEM02SEM07ABB0423ABE16634014UHG01UHM02ABS1761ABC0921ABF06133045ABM1410ABC1252
- Serial numbers CT3PZ
ACA1011ABD0501UKH01-ZADMS01ADMS02ADMS03ADPA01ADPA02ABS1353-ZADPD02ADPD03ADPD04ADPD05ADPD06ADPE01ADPE02ABM1999ADPE06ADPE05ADPG01ABP1509ADPH01ADPH02ADPH04ADPH05ADPH06ADPH07ADPE04ADPK01ADPK04ADPK05ADPK07ADPM03ADPP02ADSB0130234004ACD10064002-ZACD1621-ZADSP01UHK01-ZADSS04ADTE01ADTG01ABS1171-ZADUE01
- Serial numbers CT3Plus
- Amount recalled
- 44 systems CT3Plus; 47 systems CT3PZ
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.
Want the full recall guide?
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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