| 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 |
|
| 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 |