| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01152-1 |
| Product Name/Description |
ReNew Reusable Tips (Scissors, Graspers and Dissectors)
All Product Codes
ARTG Number 192108 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
21/09/2017 |
| Responsible Entity |
|
| Reason/Issue |
Microline Surgical has received customer reports that the heat-shrink insulation tube of ReNew Reusable Scissor, Grasper and Dissector Tips may split during autoclave sterilisation/re-sterilisation. If a split occurs, the heat-shrink could fall off during a surgical procedure and if cautery is needed, there is a potential for burn due to insulation failure.
This issue is due to a malfunction related to the heat-shrink insulation tube that is located immediately proximal to the metal tip. |
| Recall Action |
Recall |
| Recall Action Instructions |
1. Users are to complete and return the supplied response form to the sponsor, even if the affected goods are no longer in possession.
2. A CR Kennedy Representative will contact customers to:
a. Provide directions to initiate an RMA (Returned Material Authorisation) for the return of the ReNew Reusable tips at your facility.
b. Discuss the availability of ReNew Disposable Tips that are counterparts to the Reusable items (where applicable).
c. Organise a credit for all product returns to customer accounts.
This action has been closed out on 09/07/2019 |
| Contact Information |
03 9823 1565 - CR Kennedy |