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U.S. Department of Health and Human Services

Class 1 Device Recall Philips

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  Class 1 Device Recall Philips see related information
Date Initiated by Firm September 18, 2014
Date Posted October 15, 2014
Recall Status1 Terminated 3 on May 24, 2017
Recall Number Z-0048-2015
Recall Event ID 69257
510(K)Number K012218  
Product Classification Pacemaker, cardiac, external transcutaneous (non-invasive) - Product Code DRO
Product Philips HEARTSTART Multifunction Electrode Pads
Part Number: M3718A
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 151,210 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
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.
510(K) Database 510(K)s with Product Code = DRO and Original Applicant = THE LUDLOW COMPANY LP
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