| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00072-1 |
| Product Name/Description |
Roth Net Standard Polyp Retriever U-711151
Lot Numbers: 1613898, 1616337, 1616733, 1616734 and 1616735
ARTG Number: 168702 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
12/01/2017 |
| Responsible Entity |
|
| Reason/Issue |
It has been identified that the expiration date is incorrect on the outer packing label for several lots of the Roth Net device. The printed expiration date is earlier than the actual expiration date. Please note that all individual Roth Net devices inner labels reference the correct expiration date. There is no impact on the performance of the product. |
| Recall Action |
Recall |
| Recall Action Instructions |
Device Technologies is advising users to quarantine affected products prior to returning them for replacement stock. This action has been closed-out on 05/07/2017. |
| Contact Information |
03 9371 0941 - Device Technologies Product Manager |