Recall Z-2914-2016 ยท GEX Powered Laser Surgical Instrument
New Star Lasers, Inc.
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. mat
| Date | Sep 19, 2016 |
| Status | Terminated |
| 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. |
| Root cause | Labeling False and Misleading |
| 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. |
| Quantity | 44 systems CT3Plus; 47 systems CT3PZ |
| Distribution | US distribution only. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101784 | MOBICATH BI-DIRECTIONAL GUIDING SHEATH MODEL 1000182-XXX Great Batch Medical, Nov 26, 2010 |