Date Initiated by Firm | September 18, 2014 |
Date Posted | October 15, 2014 |
Recall Status1 |
Terminated 3 on May 24, 2017 |
Recall Number | Z-0046-2015 |
Recall Event ID |
69257 |
510(K)Number | K955882 |
Product Classification |
Automated external defibrillators (non-wearable) - Product Code MKJ
|
Product | Covidien Kendall 1710H Multi-Function Defibrillation Electrodes
Part Number: 40000006 |
Code Information |
Al lot codes |
Recalling Firm/ Manufacturer |
Covidien LLC 15 Hampshire St Mansfield MA 02048-1113
|
For Additional Information Contact | 508-261-8000 |
Manufacturer Reason for Recall | Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs |
FDA Determined Cause 2 | 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 customers should call (800) 962-9888, option 8, then extension 2500.
For questions regarding this recall call 508-261-8000. |
Quantity in Commerce | 133,930 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = MKJ
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