| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-00810-3 |
| Product Name/Description |
DGPHP RFA High-Power single use grounding pads and Cool-tip RFA Electrode Kits (containing DGPHP RFA High-Power single use grounding pads), Dispersive electrode used during radiofrequency lesioning procedures)
Multiple Lot Numbers
Multiple Product Numbers
ARTG Numbers: 178570 and 178245 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
8/08/2012 |
| Responsible Entity |
|
| Reason/Issue |
There is the potential for foil degradation on the DGP-HP RFA High Power single use grounding pads. This foil degradation may result in an electrical disconnect and an undesirable thermal profile during use which may result in a patient burn at the pad site. |
| Recall Action |
Recall |
| Recall Action Instructions |
Covidien is recalling the affected lots and replacing it with unaffected stock. |
| Contact Information |
1800 252 467 - Covidien |