Class I Recall: Defibrillator Electrodes

The FDA has provided more detail, and upgraded to Class I the earlier alert on defibrillator electrodes made by Covidien because of incompatibility with Philips FR3 and FRx AED units.  These Phillips defibrillators must only be used with the Philips electrodes specified in the equipment manual.  Brands and models in the alert now include:

  • Medi-Trace™ Cadence Adult Multi-Function Defibrillation Electrodes Radiotransparent (22660R)
  • Medi-Trace™ Cadence Adult Multi-Function Defibrillation Electrodes Pre-connect (22660PC)
  • Kendall™ Adult Multi-Function Defibrillation Electrodes (20660)
  • Kendall™ 1710H Multi-Function Defibrillation Electrodes (40000006)
  • MediChoice® Multifunction Electrode (MC1710H)
  • Philips HEARTSTART Multifunction Electrode Pads (M3718A)

Which totals more than half a million electrode sets.  The more detailed FDA notice is at http://www.fda.gov/Safety/Recalls/ucm418642.htm.  Class 1 Recalls are used where there is a reasonable risk of a serious adverse health consequences or death.

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