Print version of this report
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 Covidien Pty Ltd
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