| TGA Action ID |
RC-2026-RN-00860-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Uterine Curettes
Multiple models, descriptions and material numbers |
| ARTG Number |
397214 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Asherman Syndrome has been found to develop following intrauterine surgical procedures, including dilation and curettage (D&C), where injury to the uterine lining (endometrium) may occur. Asherman Syndrome is a condition where adhesions and significant scar tissue may form inside the uterus.
An additional warning is required in the Instruction for Use (IFU) and labelling to ensure that the risk of Asherman Syndrome is appropriately addressed.
The IFU of the affected devices has been updated to include information regarding intrauterine adhesions and Asherman Syndrome, together with relevant warnings. |
| Instructions for Customers/Users |
Customers are to review and follow the updated IFU supplied in the customer letter. The IFU has been updated to revision 04 with the relevant warning of Asherman Syndrome included in the warning section on page 30. |
| Action Commencement Date |
26/10/2026 |
| Responsible Entity |
|
| Contact Information |
02 9439 5316 - KLS Martin Customer Service |