| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00522-1 |
| Product Name/Description |
ConMed MacroLyte Premie Dispersive Electrode
(electrosurgical return electrode)
Lot Numbers: 1204275 to 1401075
ARTG Number: 130647 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
9/05/2014 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer has advised they have received complaints that the electrode gel may make contact with an internal staple causing no output, sparking and heat build-up between the staple and the electrode foil contact surface. Whilst there have been no complaints and no reports of injury or death received by the product Sponsor in Australia, one patient in Japan was reported to have received a skin tear. |
| Recall Action |
Recall |
| Recall Action Instructions |
ConMed is requesting their customer to immediately discontinue the use of the device and arrange for its return. This action has been closed-out on 29/01/2016. |
| Contact Information |
1800 238 238 - ConMed Australia Customer Service |