FDA Issues Class I Recall of CONMED Defibrillation Electrodes due to Risk of Death or Injury

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Los Angeles, CA: The Food and Drug Administration has classified this as a Class 1 Recall, the most serious recall where there is a reasonable risk of serious adverse health consequences or death, for certain PadPro and R2 Multi-function Defibrillation Electrodes due to a connector compatibility issue with Philips FR3 and FRx Defibrillator Units. There are a total of 174,610 electrodes affected by this voluntary device correctio

The devices are made by CONMED Corporation, which has also notified customers of a Voluntary Urgent Device Correction for the affected units. CONMED alerted customers to this issue by letter on November 6, 2014 and is in the process of revising its labeling to clarify the use of these electrodes as incompatible with the Philips FR3 and FRx AED units.

These electrodes will not connect with Philips FR3 or FRx AED units. The FRx AED unit requires the pads to be pre-connected, and will issue a continuous alarm chirp to alert the user that the proper pads are not connected to the unit prior to use. The FR3, however, does not require pre-connection and the user will not discover the incompatibility issue until the AED must be used. This may result in a delay in therapy.

The affected multi-function electrodes were distributed globally to distributors and medical facilities from March 1, 2012 through October 29, 2014.

All lot numbers of the following CONMED electrodes are affected:

Catalog Number 2001H - Adult Radiotransparent Electrode
Catalog Number 2001H-C - Adult Radiotransparent Electrode
Catalog Number 2001H-PC - Adult Radiotransparent Electrode
Catalog Number 2516H - Adult Radiotranslucent Electrode
Catalog Number 2516H-PC - Adult Radiotransparent Electrode
Catalog Number 2603H - Pediatric Radiotranslucent Electrode
Catalog Number 2602H - Mini Pediatric Radiotranslucent Electrode
Catalog Number 3115-1750 - Pediatric R2 Multifunction Electrode
Catalog Number 3115-1751 - R2 Multifunction Electrode

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