| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01165-1 |
| Product Name/Description |
Debriflo Ultrasonic Wound Irrigation Hand-piece
All Lot Numbers
ARTG Number: 265127 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
14/09/2016 |
| Responsible Entity |
|
| Reason/Issue |
It has been found that the current IFU includes an incorrect cleaning and sterilisation procedure. The IFU (Version 14) has been updated to include the new validated cleaning and sterilisation instructions, including the use of a new cleaning solution and wipes, specific dilution directions and contact times, specific lumen flushing instructions and changes to the sterilisation temperature and time. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Debriflo is providing users with a copy of the revised IFU (Version 14) with the new cleaning and sterilisation instructions.
This action has been closed out on 12/08/2019 |
| Contact Information |
02 9516 2431 - GSE |