The Mansfield, Massachusetts medical device maker said that it is withdrawing theDGPHP RFA High-Power Single Use Grounding Pads and Cool-tip RFA Electrode Kits that Contain DGPHP RFA High-Power Single Use Grounding Pads.
The affected lots were manufactured before August 30 last year and the company believes that there is a potential for a degradation of the foil within the DGPHP grounding pad.
The company has notified both its customers and the Food and Drug Administration. The FDA will review the alert and decide the seriousness of the recall by classifying it into one of Class, II or Class III categories.
The current voluntary recall follows on the heels of the FDA classifying another Covidien recall as its most serious – Class I – recall for its potential to seriously injure or kill patients. That recall involves the Covidien adult trachestomy tubesused to create a pathway to drain fluid from the lungs and trachea. But these products were leaking.
This is the second recall of a Covidien product in two months.