Tuesday, September 04, 2012

Covidien: Recall of DGPHP RFA High-Power Single Use Grounding Pads & Cool-tip™ RFA Electrode Kits

Covidien  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.
For ore information, go here: http://www.fda.gov/Safety/Recalls/ucm316017.htm