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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-00803-1
Product Name/Description	Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes, Pre-connect (used in conjunction with Automatic External Defibrillators) Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes Item Numbers: 22550PC, 22770PC Lot Numbers: 517521X, 519835X, 516313X, 519124X, 513426X ARTG Number: 186124
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	31/08/2015
Responsible Entity	Covidien Pty Ltd
Reason/Issue	This recall is being conducted due to a low-level potential for damage to the wire insulation which was identified during a review of our manufacturing process. No complaints for this issue have been reported from customers. The use of products with this condition may result in a potentially increased risk for either reduced or no patient therapy, arcing of current, sparking, and potential burns to the patient and/or clinician. No patient injuries have been reported regarding this damaged wire insulation issue.
Recall Action	Recall
Recall Action Instructions	Users are asked to immediately quarantine and discontinue use of the affected devices and to arrange return as per the instructions supplied. This action has been closed-out on 31/08/2016.
Contact Information	02 9429 3184 - Covidien