| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00908-1 |
| Product Name/Description |
HS66 Turbo LTSF Steriliser
ARTG number: 190906 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
18/08/2014 |
| Responsible Entity |
|
| Reason/Issue |
The problem identified indicates a leakage at a critical valve due to clogging of solidified formalin solution, also known as paraformaldehyde. This leakage might affect the efficacy of the LTSF sterilisation cycle and cause potential non-sterility. The problem appears stealthy until clogging has reached the level where the built-in leakage monitoring system of the steriliser is able to indicate leakage and cause an alarm. The potential risk caused by clogging is that sterile filtered air can be introduced into the sterilizer chamber during the sterilization cycle and may partially block penetration of formaldehyde at items subjected to sterilization. The risk for non-sterility is assessed to increase at hollow instruments compared to solid instruments. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
A Getinge representative will schedule a service technician visit to inspect, clean and take preventive measures at your sterilizer for the problem not to reappear.
In the meantime all users are advised to take precautions as follows:
- Depending of the occurrence and frequency of LTSF sterilization at your sterilization department use biological indicators for monitoring the sterilization efficacy at a daily or weekly basis;
- When growth is indicated by biological indicators - stop using the sterilizer and contact your Getinge representative for prompt assistance. This action has been closed-out on 03/06/2016. |
| Contact Information |
1300 155 500 - Getinge Australia |