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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