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Recall Observatory FDA recall evidence

Device product

Covidien Kendall 1710H Multi-Function Defibrillation Electrodes Part Number: 40000006

Z-0046-2015

September 18, 2014

Class I

Product summary

Firm
Covidien LLC
Event
Event 69257
Status
Terminated
Classification
Class I
Quantity
133,930 pairs
Official record key
device-enforcement:Z-0046-2015

Official wording

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

Code information: Al lot codes

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