Recalls / —
—#130111
Product
Covidien Kendall 1710H Multi-Function Defibrillation Electrodes Part Number: 40000006
- FDA product code
- MKJ — Automated External Defibrillators (Non-Wearable)
- Device class
- Class 3
- Medical specialty
- Cardiovascular
- 510(k) numbers
- K955882
- Affected lot / code info
- Al lot codes
Why it was recalled
Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs
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 #130111. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.