| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00165-1 |
| Product Name/Description |
Valleylab Laparoscopic Handset, Four-Function
Item Number: E2750
Multiple Lot Numbers
ARTG Number: 178370 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
1/02/2017 |
| Responsible Entity |
|
| Reason/Issue |
There have been customer reports of the Valleylab laparoscopic handset continuing to operate after release of the activation button. If the device continues to operate after deactivation by the user, it can increase the potential for internal tissue burn or damage. At this stage, there have been no reports of serious injury associated with this issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
Medtronic is advising users to quarantine and discontinue use of the affected products and to inform all surgeons and surgery personnel of this issue. Users are further requested to label affected stock prior to their return to Medtronic for credit.
This action has been closed out on 05/07/2019 |
| Contact Information |
02 9429 4325 - Medtronic |