Covidien Kendall 1710H Multi-Function Defibrillation Electrodes Part Number: 40000006
FDA Recall Z-0046-2015 · Posted 2014-10-15
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Recalling FirmCovidien LLC
Recall StatusTerminated
Product CodeMKJ
Date Initiated2014-09-18
Date Terminated2017-05-24
Product Quantity133,930 pairs
Reason for Recall
Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs
Firm 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 customers should call (800) 962-9888, option 8, then extension 2500.
For questions regarding this recall call 508-261-8000.
Root Cause
Device Design
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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