—#130108

Product

Covidien Medi-Trace Cadence and Kendall Adult Multi-Function Defibrillation Electrodes, Radiotransparent Part Number: 22660R

FDA product code: DRO — Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K012218
Affected lot / code info: All lots

Why it was recalled

Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs Defibrillators

Root cause (FDA determination)

Device Design

Action the firm took

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 customers should call (800) 962-9888, option 8, then extension 2500. For questions regarding this recall call 508-261-8000.

Recalling firm

Firm: Covidien LLC
Address: 15 Hampshire St, Mansfield, Massachusetts 02048-1113

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2014-09-18
Posted by FDA: 2014-10-15
Terminated: 2017-05-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #130108. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.