{ "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": "130465", "product_res_number": "Z-0053-2015", "event_date_initiated": "2014-09-16", "event_date_posted": "2014-10-09", "recall_status": "Terminated", "event_date_terminated": "2016-05-03", "res_event_number": "69409", "product_code": "MKJ", "k_numbers": [ "K943698" ], "product_description": "ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Single.\nPart number: 8900-4013\n\nProduct Usage:\nThese MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFEs are processed through Gamma Radiation to a SAL of 10-6 per International/ National Standards, EN ISO 11137-2:2012 and ANSI/AAMI/ISO 11137-2:2013, Method 1, for use in a sterile environment by trained medical professionals. The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring.", "code_info": "Lot Numbers: 1614, 1814", "firm_fei_number": "1218058", "recalling_firm": "Bio-Detek, Inc.", "address_1": "525 Narragansett Park Dr", "city": "Pawtucket", "state": "RI", "postal_code": "02861-4323", "additional_info_contact": "401-729-1400 Ext. 238", "reason_for_recall": "Product sterility is not assured", "root_cause_description": "Material/Component Contamination", "action": "Bio-Detek notiifed customers of the expanded recall on September 16, 2014 for Lot 1914 and September 22, 2014 for Lots 1614, 1814, 2114 via UPS overnight delivery. Customers were requested to return the suspect product(s) in their possession. A Device Correction Response Return Form was provided to each Customer. For questions call 1-800-348-9011 or 1-978-421-9460.", "product_quantity": "18 singles", "distribution_pattern": "Worldwide Distribution - US Nationwide and the countries of: Australia, Canada, Belgium, France, and Germany.", "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", "K033474", "K131494", "K002232", "K984286", "K143714", "K992977", "K040056", "K002806", "K073089", "K942850", "K072596", "K990762", "K011901", "K033144", "K120350", "K984582", "K082937", "K943698", "K070455", "K013896", "K052161", "K040404", "K102972", "K110526", "K940445", "K002280", "K041459", "K110361", "K063375", "K133659", "K870622", "K040438", "K052057", "K141774", "K112432", "K014209", "K962359", "K063510", "K103186", "K883341", "K955828", "K932931", "K051632", "K882067", "K122600", "K141795", "K973486", "K050004", "K040479", "K020288", "K060559", "K926172", "K965117", "K970719", "K042417", "K960329", "K052316", "K020715", "K062537", "K041883", "K983287", "K110978", "K133269", "K982025", "K073716", "K103567", "K982992", "K000638", "K021168", "K892065", "K972418", "K953204", "K955628", "K062970", "K080903", "K120406", "K991910", "K991007", "K030898", "K033771", "K993745", "K883584", "K131525", "K003548", "K092391", "K993533", "K991556", "K991871", "K071025", "K020743", "K853564", "K072812", "K150055", "K100565", "K112761", "K003228", "K012428", "K023854", "K011541", "K892005", "K941262", "K040775", "K091548", "K954957", "K952101", "K130153", "K013425", "K955882", "K942344", "K130684", "K041067", "K032439", "K051134", "K972970", "K033896", "K934692", "K932028", "K955890", "K061707", "K012030", "K031987", "K941970", "K971149", "K051076", "K121853", "K010214", "K993036", "K040256", "K032421", "K935922", "K091943", "K072233", "K082861", "K063119", "K120907", "K082090", "K113787", "K131550", "K010207", "K955854", "K060934", "K011144", "K041892", "K062177", "K982264", "K090989", "K081081", "K021453", "K022210", "K111594", "K042404", "K120536", "K925936", "K010918", "K033275", "K133484", "K142709", "K102496", "K983307", "K133239", "K092598", "K122758", "K081259", "K042088", "K133441", "K896919", "K011388", "K003819", "K033642", "K022929", "K080421", "K110154" ], "pma_number": [ "P160032", "P190013", "P160034", "P160008", "P190007", "P180028", "P200007", "P160012", "P170018", "P210015", "P200005", "P160022", "P160033", "P200004", "P160028", "P160015", "P160026" ], "registration_number": [ "", "1423537", "9681191", "3030733800", "3002807314", "3004035727", "3012494290", "3002714378", "3029871637", "3026007685", "3009077524", "3012502601", "3014579161", "3043226252", "3013517171", "1218058", "3003521780", "1921846", "3012972516", "3038259592", "3013826848", "3003537036", "3005621729", "3014572985", "1223925", "3006108746", "2112020", "1423662", "3008717264", "8020045", "3030446844", "3026976873", "3010317211", "3021559257", "9681860", "3004906872", "3010783192", "3020460367", "3010839093", "3030677", "3013596024", "3012104670", "3005906887", "3027815", "3015876", "3013557562", "3003800159", "3017422354", "3009886119", "3010030355", "3003867964", "1219103", "1317188", "1320894", "1720929", "1220908", "3013500228", "1930027", "3011823740", "3000126629", "3015997711", "2132111", "3012607778", "3010703925", "3004123209", "3015134086", "3007029079" ], "fei_number": [ "", "3030733800", "3002807314", "3004035727", "3012494290", "3002714378", "3029871637", "3026007685", "3009077524", "3012502601", "1000524572", "3001451571", "3014579161", "1000305720", "3043226252", "3013517171", "1218058", "3001236905", "3003521780", "1000148701", "1921846", "3012972516", "3038259592", "3013826848", "3003537036", "3005621729", "3014572985", "3006108746", "2112020", "3008717264", "3008207730", "3030446844", "3026976873", "3010317211", "3021559257", "1000127185", "3004906872", "6736", "3010783192", "3020460367", "3010839093", "3000215273", "3012104670", "3013596024", "3005906887", "1000140026", "3015876", "3013557562", "3003800159", "3017422354", "3009886119", "3010030355", "3003867964", "1317188", "1720929", "1220908", "3013500228", "1930027", "3011823740", "3000126629", "3003491392", "3015997711", "3012607778", "3010703925", "3004123209", "3015134086", "3007029079" ], "device_name": "Automated External Defibrillators (Non-Wearable)", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.5310", "device_class": "3" } } ] }