Home / Recalls / Medical Devices
Nellcor Puritan Bennett Inc. (dba Covidien LP) recalls DGPHP RFA High-Power Single Use Grounding Pads and Cool-Tip RFA Electrode Kits (containing DGPHP RFA High-Power single u
Recalled September 5, 2012 · FDA recall Z-2301-2012 · Nellcor Puritan Bennett Inc. (dba Covidien LP)
Hazard
Covidien is conducting a recall of various production lots of DGHP RFA High Power single use grounding pads and Cool-tip RFA Electrode Kits due to the potential for foil degradation on the DGP-HP single use grounding pad which may result in an electrical burn to the patient at the application site. · FDA Class II
Units
184,934 units
Sold at
Worldwide distribution: USA (nationwide) and countries including: Australia, Brazil, Canada, Columbia, Deutchland, France, Japan, Mexico, Panama, Puerto Rico, Singapore, and Uruguay.
Description
Covidien is conducting a recall of various production lots of DGHP RFA High Power single use grounding pads and Cool-tip RFA Electrode Kits due to the potential for foil degradation on the DGP-HP single use grounding pad which may result in an electrical burn to the patient at the application site.
Product
DGPHP RFA High-Power Single Use Grounding Pads and Cool-Tip RFA Electrode Kits (containing DGPHP RFA High-Power single use grounding pads) The product is used during ablation surgical procedures.
Manufacturer(s)
Nellcor Puritan Bennett Inc. (dba Covidien LP)
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →