The Therapeutic Goods Administration (TGA) of Australia has posted a medical device safety alert concerning Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes (Pre-Connect), manufactured by Covidien. The affected item numbers are 22550PC and 22770PC, with lot numbers 517521X, 519835X, 516313X, 519124X and 513426X.
According to the alert, a recall was being conducted due to a low-level potential for damage to the wire insulation which was identified during a review of the manufacturing process.
The use of products with this condition may result in a potentially increased risk for reduced or no patient therapy, arcing of current, sparking, and patient and/or clinician burns. According to the safety alert, no patient injuries have been reported related to this damaged wire insulation issues.
Users are advised to immediately quarantine and discontinue use of the affected devices.
For details, please refer to the TGA website:
http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2015-RN-00803-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 2 September 2015