FDA-Device2013-05-08Class II

Medi-Trace Cadence Adult Radiotransparent Defibrillation Electrode Product ID: 22550R. Intended for use in cardioversion, pacing, ECG monitoring, and defibrillation procedures.

Covidien LLC
Hazard

Defibrillation Electrodes may arc/spark result in thermal damage to the leadwire, which could render the device incapable of delivering the appropriate energy or shock to the patient

Sold states
Worldwide Distribution-USA (nationwide) and the countries of Korea, Japan, Canada, Australia, Brazil, Belgium, Singapore, and South Africa.
Affected count
133470 (sets of 2)
Manufactured in
15 Hampshire Street, Mansfield, MA, United States
Products
Medi-Trace Cadence Adult Radiotransparent Defibrillation Electrode Product ID: 22550R. Intended for use in cardioversion, pacing, ECG monitoring, and defibrillation procedures.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1184-2013

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