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Health product recall

DGPHP RFA High-Power Single Use Grounding Pads and Cool-Tip RFS Electrode Kits

Starting date:
August 7, 2012
Posting date:
September 3, 2012
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type I
Source of recall:
Health Canada
Issue:
Product Safety, Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-15532

Recalled Products

A. DGPHP RFA High-Power Single Use Grounding Pads and Cool-Tip RFS Electrode Kits

Reason

This recall is being conducted due to the potential for foil degradation on the DGPHP RFA High-Power Single Use Grounding Pads. This foil degradation may result in an electrical disconnect and undesirable thermal profile during use which may result in a serious burn at the patient pad site.

Affected products

A. DGPHP RFA High-Power Single Use Grounding Pads and Cool-Tip RFS Electrode Kits

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

More than 10 numbers, contact manufacturer.

Companies
Manufacturer
Covidien LLC