CLASS I Device recall · Reported 22 Oct 2014 · FDA Enforcement Report
Kendall 1710H Multi-Function Defibrillation Electrodes recalled
Covidien is recalling Covidien Kendall 1710H Multi-Function Defibrillation Electrodes, distributed nationwide in the US. The recall was initiated on 18 Sep 2014 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0046-2015
- FDA event ID
- 69257
- Recalling firm
- Covidien, Mansfield, MA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 18 Sep 2014
- FDA classified
- 16 Oct 2014
- Reported
- 22 Oct 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 18 Sep 2014 | Recall initiated by company | |
| 16 Oct 2014 | Classified by FDA | +28 days |
| 22 Oct 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs
Product as listed by the FDA
Covidien Kendall 1710H Multi-Function Defibrillation Electrodes Part Number: 40000006
Where it was distributed
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.
Questions about this recall
Is Kendall 1710H Multi-Function Defibrillation Electrodes recalled?
Yes. Covidien recalled Kendall 1710H Multi-Function Defibrillation Electrodes on 18 Sep 2014. The recall is Class I and its status is Terminated. Recall number Z-0046-2015.
Why was it recalled?
Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs
Which lots are affected?
Al lot codes
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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