Type of Product |
Medical Device |
TGA Recall Reference |
RC-2012-RN-01204-1 |
Product Name/Description |
ENSEAL G2 Curved and Straight Tissue Sealer Devices (used in endoscopic procedures)
Multiple product codes
All lots with expiration date from October 2013 to September 2017
ARTG Number: 125257 |
Recall Action Level |
Hospital |
Recall Action Classification |
Class II |
Recall Action Commencement Date |
28/11/2012 |
Responsible Entity |
|
Reason/Issue |
Johnson & Johnson Medical advises that there is a potential for self activation while the device is in use, which could result in injury to patients or users (thermal damage). |
Recall Action |
Recall |
Recall Action Instructions |
Quarantine and return affected product to Johnson & Johnson Medical. |
Contact Information |
1800 252 194 (Option 1) - Johnson & Johnson Medical Customer Service |