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Type of Product Medical Device
TGA Recall Reference RC-2014-RN-01034-1
Product Name/Description Covidien Medi-Trace Cadence Defibrillation Electrodes

Product Code: 22660R

ARTG: 186124
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 25/09/2014
Responsible Entity Covidien Pty Ltd
Reason/Issue Covidien has received two reports where customers attempted to use a Covidien electrode with a Philips FR3 AED unit. These electrodes will not connect with Philips FR3 or FRx AED units, and in the case of the use of Covidien defibrillation electrodes with the Philips FR3 AED units, could result in a delay of therapy. 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.
Recall Action Recall for Product Correction
Recall Action Instructions Covidien is modifying the labelling to clarify that use of the affected electrodes are incompatible with certain AED units. This action has been closed-out on 18/03/2016.
Contact Information 02 9429 3184 - Covidien Pty Ltd