ConMed Pediatric Electrodes Recalled Due to Connection Design Changes
ConMed is recalling 174,610 pediatric electrodes because design changes to Philips AEDs may prevent connection, delaying therapy and risking death or serious injury.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly states that the failure to connect may result in patient death or serious injury, which meets the rubric criteria for a Critical severity score.
Plain-English summary
ConMed Corporation is recalling 174,610 units of the MINI PEDIATRIC Radiotransparent Electrode, catalog number 2602H. These single-use, disposable devices are intended for use during defibrillation, cardioversion, pacing, and ECG monitoring applications. The recall affects all lot codes and includes 168,090 units distributed in the United States and 6,520 units distributed outside the US.
The recall is being conducted because Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. This design change may result in a failure to connect the electrodes to the devices. A failure to connect may result in a delay of therapy, which could result in patient death or serious injury.
The affected products were distributed worldwide, including nationwide in the United States, Puerto Rico, and internationally to Bosnia, Herzegovina, Brazil, Canada, Great Britain, Israel, Italy, Republic of Korea, Norway, Portugal, Saudi Arabia, and Spain. Users should stop using these electrodes and contact ConMed Corporation for instructions on how to return the product.
The recalled product
- Product
- MINI PEDIATRIC Radiotransparent Electrode, REF/Catalog Number 2602H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR--Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring applications. This product is a single-use,
- Manufacturer
- ConMed Corporation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Lot Codes
Distribution
Part of a larger recall action
This product is one of 9 recalled by ConMed Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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