| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00328-1 |
| Product Name/Description |
EnSeal G2 SuperJaw (Used for bipolar coagulation and mechanical transection of tissue during laparoscopic and open procedures)
Product Code: NSEALX22L
ARTG Number: 165469 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
17/04/2013 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer has identified an increase in Adverse Events with ENSEAL G2 Superjaw for suspected thermal injuries related to the use of the device. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Johnson & Johnson Medical (JJM) is updating the instructions for use to prevent the issues from occurring in the field. JJM has advised the TGA that they are further reviewing the post-market surveillance data and will advise the TGA regarding the outcomes of this review. |
| Contact Information |
02 9815 3776 - JJM Quality Assurance |