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Recall Observatory FDA recall evidence

Device product

Covidien Medi-Trace Cadence and Kendall Adult Multi-Function Defibrillation Electrodes, Radiotransparent Part Number: 22660R

Z-0043-2015

September 18, 2014

Class I

Product summary

Firm
Covidien LLC
Event
Event 69257
Status
Terminated
Classification
Class I
Quantity
317,550 pairs
Official record key
device-enforcement:Z-0043-2015

Official wording

Reason: Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs Defibrillators

Code information: All lots

Distribution pattern: Worldwide Distribtion-USA (nationwide) including Puerto Rico and the countries of Canada Greece Israel Belgium Finland France Germany Great Britain Ireland Italy Norway Poland Portugal Spain Sweden Switzerland Brazil Chile Philippines Taiwan Australia New Zealand.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs Defibrillators