| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00397-1 |
| Product Name/Description |
Diego Elite Tubesets
Item Codes:
TS100S – Diego Elite Tubeset, Standard
TS101DC – Diego Elite Tubeset, Declog
ARTG Number: 143268 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
12/05/2015 |
| Responsible Entity |
|
| Reason/Issue |
The reason for the recall is due to a possible breach of the package’s sterile barrier, therefore compromising the sterility of the product. The breach may not be easily seen. It is important to note that there are no concerns regarding the Diego Elite product performance. However, as a result there has been a temporary disruption in the supply of Diego Elite tube sets. |
| Recall Action |
Recall |
| Recall Action Instructions |
End users are requested to cease use of any affected product and quarantine it until it is shipped back to Olympus Australia Pty Ltd. This action has been closed-out on 08/08/2016. |
| Contact Information |
1300 132 992 - Olympus Customer Service |