Recall Z-0043-2015 ยท DRO Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
Covidien LLC
Covidien Medi-Trace Cadence and Kendall Adult Multi-Function Defibrillation Electrodes, Radiotransparent Part Number: 22660R
| Date | Oct 15, 2014 (initiated Sep 18, 2014) |
| Status | Terminated |
| Reason | Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs Defibrillators |
| Root cause | Device Design |
| Action | Covidien notified customers by letter via Federal Express on 9/18/14. The letter requests that they immediately verify that they are not stocking Covidien electrodes for use with Philips FR3 or FRx AED units. A customer reply acknowledgement form is provided to allow Covidien to track the effectiveness of the notification. Covidien is adding a label to all levels of packaging that alerts the user that the product is not compatible with the FR3 and FRx AED units. Distribution partners notified to address product in the distribution chain that is available to be relabeled. For questions cust |
| Quantity | 317,550 pairs |
| Distribution | Worldwide Distribtion-USA (nationwide) including Puerto Rico and the countries of Canada Greece Israel Belgium Finland France Germany Great Britain Ireland Italy Norway Poland Portugal Spain Sweden Switzerland Brazil Chile Philippines Taiwan Australia New Zealand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012218 | LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES The Ludlow Company LP, Oct 12, 2001 |