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
MedSun: Newsletter #76, September 2012

FDA Recalls, Market Withdrawals and Safety Alerts

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.

Additional Information:

FDA Recalls, Market Withdrawals and Safety Alerts. 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. August 17, 2012
http://www.fda.gov/Safety/Recalls/ucm316017.htm


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