| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01073-1 |
| Product Name/Description |
TDL6000MC Disposable Diathermy - Spatula tip with handle (Electrosurgical electrode)
Lot Number: 1219857
ARTG Number: 198434 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
16/10/2013 |
| Responsible Entity |
|
| Reason/Issue |
The recall is due to the two pieces of insulation on the handle not overlapping sufficiently, allowing the diathermy pen to spark through the insulation join when used with high voltage.
This recall action was carried out prior to approval of the recall communication by the TGA. |
| Recall Action |
Recall |
| Recall Action Instructions |
Life Healthcare has removed the affected stock from the customers. The manufacturer has redesigned the insulation to a one piece construction to remove the failure mode. |
| Contact Information |
02 8114 1551 - Regulatory Affairs |