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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