| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01331-1 |
| Product Name/Description |
Lumenis FemTouch Delivery System (used with AcuPulse laser system and AcuScan120 microscanner for gynecological treatments)
FemTouch Kit
Model Number: AC-1007415
FemTouch Tip (supplied in FemTouch Kit)
Part Number: SPSA-20002590
ARTG Number: 204126 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
7/11/2016 |
| Responsible Entity |
|
| Reason/Issue |
Lumenis have learned that the cleaning instructions provided in FemTouch Operator’s Manual (UM-10065340 Rev. B) might be ineffective for a fully assembled device and may lead to a potential for cross-contamination. Lumenis initiated a re-verification of the cleaning protocol, and the results showed the current protocol as stated in the Instructions For Use (IFU) were not effective for an assembled handpiece (tip). This issue affects all FemTouch hand pieces and kits. Lumenis has not received any reports of injury or harm associated with this potential risk. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Lumenis is asking customers to disassemble the FemTouch tip prior to its cleaning process. This will remove cleaning challenges and allow the device to be effectively cleaned and sterilised using the protocol in the labelling, thereby reducing the potential for cross-contamination.
This action has been closed out on 06/11/2018 |
| Contact Information |
03 9863 7823 - Lumenis Australia |