Article
Defibrillation Electrodes Voluntarily Recalled Due to Incompatibility
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CONMED Corporation is voluntarily recalling some of its PadPro and R2 multi-function defibrillation electrodes due to a connector compatibility problem with Philips FR3 and FRx defibrillator units.
CONMED Corporation is voluntarily recalling some of its PadPro and R2 multi-function defibrillation electrodes due to a connector compatibility problem with Philips FR3 and FRx defibrillator units, according to the FDA.
If users try to connect these electrodes to a FRx defibrillator unit, it will set off an alarm alerting the user that the proper pads are not connected. With the FR3, there is no alert pre-connection, so the user will not discover the incompatibility issue until the moment of use. These 2 problems may cause a delay in therapy, according to the FDA.
The affected electrodes, which total 174,610, were distributed from March 1, 2012, through October 29, 2014. None of them need to be returned to CONMED, according to the FDA.
The following electrodes are affected: Catalog Number 2001H, 2001H-C, 2001H-PC, 2516H, 2516H-PC, 2603H, 2602H, 3115-1750, and 3115-1757.
Consumers can report a problem or receive more information by calling CONMED at 727-399-5276 Monday through Friday from 8 AM to 5 PM Eastern Time or by emailing multifunctionelectrodes@conmed.com.
In addition, anyone who has experienced an adverse reaction to the products can report it to the FDA’s MedWatch by downloading a form at www.fda.gov/MedWatch/getforms.htm and submitting it online, or by requesting the form by phone at 1-800-332-1088 and mailing it in or submitting it via fax to 1-800-FDA-0178.
