Medical device manufacturer, Covidien, has issued a field safety notice concerning DGPHP RFA High-Power single use grounding pads and Cool-tip RFA Electrode Kits (containing DGPHP RFA High-Power single use grounding pads).
The manufacturer is voluntarily recalling various production lots of the DGPHP RFA High- Power single use grounding pads and Cool-tip RFA Electrode Kits (containing DGPHP RFA High-Power single use grounding pads). Serious injuries have occurred due to the failure of this product. The manufacturer has received four reports of serious injuries involving patient burns at the DGPH pad site.
According to the local supplier, Covidien Hong Kong Ltd., the affected devices were distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 10 August 2012