{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "130111", "product_res_number": "Z-0046-2015", "event_date_initiated": "2014-09-18", "event_date_posted": "2014-10-15", "recall_status": "Terminated", "event_date_terminated": "2017-05-24", "res_event_number": "69257", "product_code": "MKJ", "k_numbers": [ "K955882" ], "product_description": "Covidien Kendall 1710H Multi-Function Defibrillation Electrodes\nPart Number: 40000006", "code_info": "Al lot codes", "firm_fei_number": "1282497", "recalling_firm": "Covidien LLC", "address_1": "15 Hampshire St", "city": "Mansfield", "state": "MA", "postal_code": "02048-1113", "additional_info_contact": "508-261-8000", "reason_for_recall": "Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs", "root_cause_description": "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.\nFor questions regarding this recall call 508-261-8000.", "product_quantity": "133,930 pairs", "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.", "openfda": { "k_number": [ "K970741", "K883344", "K142803", "K954504", "K955923", "K141231", "K072923", "K981737", "K032051", "K982710", "K860676", "K111693", "K003565", "K981802", "K972241", "K122839", "K110825", "K992543", "K142915", "K150198", "K014157", "K091265", "K062233", "K042007", "K091561", "K012197", "K081371", "K012766", "K110168", "K954609", "K990106", "K020203", "K002079", "K001725", "K002445", "K971148", "K072430", "K080232", "K031187", "K081828", "K051475", "K110742", "K010634", "K980857", "K052465", 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