Covidien Kendall Adult Multi-Function Defibrillation Electrodes Part Number: 20660
FDA device recall Z-0045-2015 · posted 2014-10-15 · Terminated
Recall details
- Recalling firm
- Covidien LLC
- Reason for recall
- Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- DRO
- Quantity affected
- 31,590 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 Sw
- Date initiated
- 2014-09-18
- Date posted
- 2014-10-15
- Date terminated
- 2017-05-24
- Location
- Mansfield, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES (K012218) | The Ludlow Company LP | 2001-10-12 |