| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00651-1 |
| Product Name/Description |
Anspach Attachments and Handpieces (reusable surgical devices)
Multiple part numbers and lot numbers
ARTG Numbers: 141597, 141559, 141600, 146267 and 155913 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
17/06/2014 |
| Responsible Entity |
|
| Reason/Issue |
Internal testing of STERRAD® 100S sterilisation process has shown that several Anspach attachments and handpieces did not achieve the expected sterility assurance level (SAL) of 10-6. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Synthes Australia is notifying their customers of the removal of the recommendation to sterilise Anspach Attachments and Handpieces in the STERRAD 100S (Hydrogen Peroxide Gas Plasma Technology). Steam sterilisation method is still validated for the sterilisation of these devices. |
| Contact Information |
02 9855 4620 - Synthes Australia |