FDA-Device2012-09-05Class II
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.
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.
Sold states
Worldwide distribution: USA (nationwide) and countries including: Australia, Brazil, Canada, Columbia, Deutchland, France, Japan, Mexico, Panama, Puerto Rico, Singapore, and Uruguay.
Affected count
184,934 units
Manufactured in
6135 Gunbarrel Ave, N/A, Boulder, CO, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2301-2012Don't want to check this manually?
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