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TGA Action ID	RC-2025-RN-00014-1
Type of Product	Medical Device
Product Name/Description	MCL31 DERMABLATE & JULIET HANDPIECE WITH STERISPOT COVERS MCL31 DERMABLAT Serial No: 182000729, 182000745, 182000747, 182000786, 182000811, 182000865, 182000867, 182000873, 182000895, 182000954, 182001005, 182001135 182001595, 182001628 JULIET HANDPIECE Serial No: 390100120, 390100163, 390100187, 390100203, 390100205, 390100228, 390100247, 390100304, 390100306, 390100309, 390100347, 390100477, 390100528, 390100653, 390100786, 390100790 ARTG 234391
ARTG Number	234391
Action Type	Recall
Action Level	Retail
Hazard Classification	Class II
Reason for the Action	The TGA has completed a post-market review of all energy-based devices used for vaginal rejuvenation included in the Australian Register of Therapeutic Goods (ARTG). The review found there was insufficient clinical evidence to support the therapeutic use and long-term safety of these devices. Claims related to genitourinary indications and the use of associated handpieces have been removed from the Instructions for Use (IFU) for the MCL31 Dermablate device. The Juliet handpiece with SteriSpot covers, which was specifically for genitourinary indications has been withdrawn from the market. The MCL31 Dermablate device continues to be included on the ARTG and is not affected by the recall except for the amendment to the IFU. MCL31 Dermablate can continue to be used for all non-genitourinary applications as per the IFU and in accordance with the indications included on the ARTG.
Instructions for Customers/Users	Recall: Device Consulting will contact customers to arrange for return of the Juliet handpieces Product Defect Correction: Device Consulting will contact customers to replace the IFU customers currently have for the MCL31 Dermablate. This action has been finalised on 21/7/2025.
Action Commencement Date	10/01/2025
Responsible Entity	Device Consulting Pty Ltd
Contact Information	03 9998 2020 - Device Consulting