Recall targets defibrillation electrodes
CONMED is alerting customers about connector incompatibility issues with defibrillation electrodes in automated external defibrillators (AEDs) in a Class 1 recall.
The voluntary notice applies to CONMED PadPro and R2 Multifunction defibrillation electrodes. The company reported that the electrodes don’t connect with Philips FR3 and FRx AED defibrillator units.
This is the second recent report of a defibrillation electrode mismatch with the two Philips AEDs that led to a recall.
Electrodes with the following lot numbers were distributed between March 1, 2012, and Oct. 29, 2014:
- 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
Customers do not need to send the electrodes back to CONMED. The Utica, N.Y.-based company is revising the labeling to clarify the incompatibility issue.