| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00922-1 |
| Product Name/Description |
Covidien Valleylab Laparoscopic Wire Retractable Electrode (used in laparoscopic and thoracic surgeries for electrosurgical cutting and coagulation)
Multiple Item Codes and Lot Numbers affected
ARTG Numbers: 178655, 178370 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
11/07/2016 |
| Responsible Entity |
|
| Reason/Issue |
This recall action is being conducted due to the potential for compromise of the packaging resulting in a breach of the sterile barrier. The use of products with this packaging defect may increase risk of infection. There have been no reports of serious injury associated with this issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
Covidien is advising users to inspect and quarantine any remaining unused products for return for credit. There is not a replacement product available at this time. This action has been closed-out on 10/05/2017. |
| Contact Information |
02 9429 4325 - Covidien |