FDA-Device2013-05-22Class II
PadPro(R) Adult Radiotransparent Multifunction Electrodes, REF/Catalog No. 2001M-C. The PadPro(R) Adult Radiotransparent Multifunction Electrodes with Carbon Leadwires and Medtronic(R) Connector are intended to be used in external pacing, defibrillation and monitoring applications
ConMed Corporation
Hazard
ConMed was notified by the contract manufacturer that their wire/connector supplier reported damage to the connector tooling which could pinch or compress the lead wire filaments and potentially render the device incapable of delivering the appropriate energy or shock to the patient and/or could cause potential injury to user or patient.
Sold states
Worldwide distribution: USA (nationwide) and the country of: Saudi Arabia.
Affected count
Domestic: 49,010; Foreign: 600
Manufactured in
525 French Road, Utica, NY, United States
Products
PadPro(R) Adult Radiotransparent Multifunction Electrodes, REF/Catalog No. 2001M-C. The PadPro(R) Adult Radiotransparent Multifunction Electrodes with Carbon Leadwires and Medtronic(R) Connector are intended to be used in external pacing, defibrillation and monitoring applications
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1317-2013Don't want to check this manually?
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