{ "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": "149595", "product_res_number": "Z-0004-2017", "event_date_initiated": "2016-09-01", "event_date_posted": "2016-10-14", "recall_status": "Terminated", "event_date_terminated": "2019-03-26", "res_event_number": "75181", "product_code": "MKJ", "k_numbers": [ "K142803" ], "product_description": "Skintact Electrodes for Defibrillation, DF29N.\n\nProduct Usage:\nMultifunction electrode for external defibrillation, pacing, cardioversion, and monitoring. The device is non-sterile and for single use only.", "code_info": "US: 60602-0774; 60502-0779; 60308-0771; 60114-0773; 51023-0775; 50904-0777; 50403-0778; 50130-0777; 41023-0771; 41008-0778; 40730-0778; 40618-0778; and, 40130-0776. Outside US: 60725-0774; 60620-0776; 60602-0774; 60502-0779; 60308-0771; 60114-0773; 51023-0775; 50904-0777; 50403-0778; 40827-0777; 40730-0778; 40618-0778; and, 40130-0776.", "firm_fei_number": "6736", "recalling_firm": "Leonhard Lang Medizintechnik GmbH", "address_1": "Archenweg 56 56 archenweg", "city": "Innsbruck", "country": "Austria", "reason_for_recall": "There is a risk that defibrillation electrodes model DF29N will be connected with the defibrillator Welch Allyn AED 10 only with delay or not at all. This may cause a situation in which a patient, who is in a life threatening condition and requires a\ndefibrillation shock, cannot be treated in good time.", "root_cause_description": "Device Design", "action": "Consignees was sent via e-mail a Leonhard Lang \"Important Safety Notice\" dated September 1, 2016. The letter described the product being recalled, Description of the defect, Actions and time frame of the recall, & Compensation for the recalled electrodes. Advised consignees to inform all users within their organizations of the recall; and, secure and destroy the unused electrodes in their inventory. Confirmation of destruction can be done by completing and returning the \"Confirmation of Destruction / Consumption\" form by October 14, 2016. If the product was further distributed, they were to forward a copy of the Safety Notice. For questions contact sales staff.", "product_quantity": "11,110 ( US 8,040; OUS 3,070)", "distribution_pattern": "Worldwide Distribution - US, to the state of Florida; and, the countries of South Africa, Germany, Slovenia, France, United Arab Emirates, Great Britain, Italy, Israel, Serbia, Thailand, Thailand, South Africa, Lebanon, and Poland.", "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", "K970391", "K142430", "K964991", "K983393", "K123881", "K130454", "K040637", "K010257", "K020984", "K993072", "K022732", 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"medical_specialty_description": "Cardiovascular", "regulation_number": "870.5310", "device_class": "3" } } ] }