|Covidien Initiates a Voluntary Recall of DGPHP RFA High-Power Single Use Grounding Pads and Cool-tip™ RFA Electrode Kits that Contain DGPHP RFA High-Power Single Use Grounding Pads|
MANSFIELD, MA – August 17, 2012 -- Covidien today announced that it is conducting a voluntary recall of certain production lots of the DGPHP RFA High-Power Single Use Grounding Pads and Cool-tip™ RFA Electrode Kits that contain DGPHP RFA High-Power Single Use Grounding Pads.
Covidien has voluntarily decided to recall specific lots manufactured prior to August 30, 2011, due to the potential degradation of foil within the DGPHP grounding pad. Covidien has received reports of four serious injuries, burns at the pad site on the patient, which may be related to this product quality issue.
The affected product descriptions and lots are as follows:
* Lot Numbers may contain a suffix “X”
Covidien is working with the United States Food and Drug Administration (FDA) and other regulatory authorities on this voluntary recall.
Customers have been notified of this recall by letter on August 6, 2012. Please return the affected product by contacting Customer Service at SDFeedback@Covidien.com or 1-800-722-8772, option 1, to obtain a Return Goods Authorization prior to returning the affected units.
Healthcare professionals and customers may report adverse events or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by phone or by fax.