{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "210723", "product_res_number": "Z-0503-2025", "event_date_initiated": "2024-10-14", "event_date_posted": "2024-11-25", "recall_status": "Open, Classified", "res_event_number": "95594", "product_code": "MKJ", "pma_numbers": [ "P160032" ], "product_description": "Defibtech DDP-200P: Pediatric Defibrillation Pads 0 For use with AED Models: Lifeline and\nLifeline Auto (DDU-l XX Series)-Indicated for use on victims of sudden cardiac arrest (SCA.)", "code_info": "UDI-DI:\n00815098020430, DDP-200P pediatric defibrillation pads, single pair;\n10815098020437, DDP-200P pediatric defibrillation pads, single pair configuration;\n40815098020438, DDP-200P pediatric defibrillation pads, 20 pairs", "firm_fei_number": "3003521780", "recalling_firm": "Defibtech, LLC", "address_1": "741 Boston Post Rd", "address_2": "Suite 201", "city": "Guilford", "state": "CT", "postal_code": "06437-2714", "additional_info_contact": "Defibtech Customer Service\n203-453-6654", "reason_for_recall": "Within the Irish Market, that a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the authorized label removed and an unauthorized\nlabel applied, could potentially lead to expired Defibtech AED Pads appearing as though they are within the acceptable shelf life.there is a possibility of hydrogel drying, which may result in poor\nelectrical connection to the patient, which can reduce the energy delivered to the patient", "root_cause_description": "Under Investigation by firm", "action": "Defibtech issued Urgent Field Safety Notice on 10/14/24 by e-mail to the Irish Market h via the Distributor Oxygen Care Ltd. titled: Unauthorized Label Applied to Defibtech, LLC's Automated External Defibrillator (AED} Pads within the Irish Market.\n\n Letter states reason for recall, health risk and action to take:\nActions to be taken by the Customer/User:\n1. Check the label of your Defibtech AED Pads. Please review Attachment B which clearly shows authorised labelled Defibtech AED Pads versus unauthorised labelled Defibtech AED Pads.\n2. Please confirm receipt of this notice by completing Attachment C \"Customer Reply Form\", attached to this notice, and return to Oxygen Care, Ltd (our new official Irish Distributor) so that our records may be updated.\n3. If an unauthorised label applied to Defibtech AED Pads is confirmed, please urgently return the Defibtech AED Pads along with the completed \"Customer Reply Form\" to Oxygen Care. Upon receipt of the unauthorized labelled Defibtech AED Pads, Oxygen Care will send a replacement set of authorised labelled Defibtech AED Pads to you at no charge:\nOxygen Care Ltd.:\nEmail: Sales@ oxyge n-care.ie\nPhone: 01 2769700\nAddress: 2 Holfeld Business Park, Kilmacanogue. Co. Wicklow. Eircode A98 NP27\n4. If you have transferred the Defibtech AED Pads to another entity or department, please contact Oxygen Care as per the above contact details.\nThe unauthorised labelled Defibtech AED pads were re-labelled with expiration dates beyond the shelf life of the Defibtech AED Pads. The affected Defibtech AED Pads should not be used.\nDefibtech will continue to work closely with regulatory authorities toward the resolution of this issue.\nDefibtech is committed to patient safety and is focused on providing the highest level of customer satisfaction. We appreciate your cooperation and sincerely apologize for any inconvenience this may cause you.", "product_quantity": "22,294 total", "distribution_pattern": "Ireland", "openfda": { "k_number": [ "K032439", "K971148", "K896919", "K992543", "K860676", "K983393", "K003565", "K040256", "K091561", "K031187", "K853564", "K030898", "K011144", "K103567", "K953204", "K955628", "K120406", "K111594", "K012766", "K002232", "K133484", "K150055", "K120536", "K993036", "K122600", "K020984", "K033771", "K993072", "K120907", "K060934", "K072430", "K110825", "K063510", "K041067", "K111693", "K130684", "K010214", "K063119", "K091265", "K123881", "K962359", "K932931", "K062177", "K942850", "K092598", "K943698", "K002445", "K142430", "K143714", "K955923", "K080421", "K040438", "K120350", "K935922", "K061707", "K012428", "K980857", "K003548", "K141774", "K040404", "K990762", "K112432", "K991556", "K954957", "K122839", "K100565", "K011901", "K052057", "K113787", "K040637", "K002806", "K081081", "K964991", "K041883", "K090989", "K072812", "K022732", "K934692", "K062537", "K062970", "K032051", "K133441", "K882067", "K082937", "K955828", "K133269", "K970391", "K992977", "K142915", "K942344", "K940445", "K001725", "K131494", "K991007", "K022210", "K973486", "K051134", "K041459", "K022929", "K990106", "K052161", "K002280", "K926172", "K081259", "K993745", "K955882", "K981802", "K991910", "K072233", "K033474", "K073716", "K011541", "K060559", "K954504", "K981737", "K991871", "K070455", "K972418", "K883344", "K955890", "K040479", "K003228", "K141795", "K954609", "K010634", "K012197", "K033642", "K062233", "K131550", "K040056", "K110154", "K925936", "K982710", "K972970", "K941262", "K142803", "K984582", "K883584", "K133239", "K970719", "K021168", "K052465", "K971149", "K131525", "K020743", "K952101", "K003819", "K972241", "K033275", "K002079", "K012030", "K051076", "K102972", "K014157", "K892005", "K072596", "K011388", "K112761", "K970741", "K965117", "K052316", "K010918", "K982264", "K051632", "K080903", "K141231", "K080232", "K110361", "K122758", "K870622", "K932028", "K010207", "K031987", "K010257", "K021453", "K020288", "K050004", "K020715", "K982992", "K071025", "K121853", "K983287", "K013896", "K091548", "K110978", "K081371", "K082090", "K130454", "K955854", "K982025", "K042404", "K040775", "K103186", "K892065", "K110742", "K133659", "K081828", "K063375", "K983307", "K072923", "K130153", "K110168", "K042007", "K092391", "K142709", "K041892", "K150198", "K033144", "K082861", "K020203", "K960329", "K042417", "K013425", "K091943", "K033896", "K941970", "K102496", "K110526", "K042088", "K073089", "K000638", "K032421", "K883341", "K984286", "K014209", "K023854", "K993533", "K051475" ], "pma_number": [ "P160032", "P210015", "P200007", "P160033", "P160015", "P160022", "P160012", "P160008", "P190007", "P200004", "P190013", "P200005", "P160026", "P170018", "P160028", "P160034", "P180028" ], "registration_number": [ "3030733800", "", "3026007685", "3003867964", "3013517171", "2132111", "1220908", "3020460367", "3010783192", "3003800159", "3010703925", "3012494290", "2112020", "3010839093", "3015997711", "1720929", "3004123209", "3017422354", "3004035727", "3026976873", "3005906887", "1317188", "3015134086", "3012104670", "3000126629", "3043226252", "3013500228", "1219103", "3004906872", "3003537036", "3014572985", "1423537", "3011823740", "1423662", "3021559257", "3010030355", "3012972516", "3005621729", "3038259592", "3029871637", "3007029079", "3013596024", "3008717264", "1930027", "3010317211", "3013826848", "3012607778", "3030446844", "3030677", "1218058", "3027815", "3002807314", "9681860", "3009077524", "9681191", "1320894", "3013557562", "3009886119", "1223925", "3003521780", "3002714378", "3006108746", "3014579161", "8020045", "1921846", "3012502601", "3015876" ], "fei_number": [ "3030733800", "", "3026007685", "3003867964", "3013517171", "3007029079", "1220908", "3020460367", "3010783192", "3003800159", "3010703925", "3012494290", "2112020", "3010839093", "3001236905", "3015997711", "3004123209", "1720929", "3017422354", "3004035727", "3026976873", "3005906887", "1317188", "3015134086", "3012104670", "3000126629", "3043226252", "1000127185", "6736", "3013500228", "3003537036", "3004906872", "3014572985", "3011823740", "3021559257", "3010030355", "3012972516", "3005621729", "3038259592", "1000305720", "3029871637", "3013596024", "3008717264", "3003491392", "3010317211", "3013826848", "3012607778", "1930027", "1000140026", "3030446844", "3000215273", "1218058", "3002807314", "3009077524", "3013557562", "3009886119", "3003521780", "3002714378", "3006108746", "1000524572", "3014579161", "1921846", "3001451571", "1000148701", "3008207730", "3012502601", "3015876" ], "device_name": "Automated External Defibrillators (Non-Wearable)", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.5310", "device_class": "3" } } ] }