{ "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": "40482", "product_res_number": "Z-0004-06", "event_date_initiated": "2005-07-12", "event_date_posted": "2005-10-04", "recall_status": "Terminated", "event_date_terminated": "2006-06-26", "res_event_number": "32642", "product_code": "MKJ", "k_numbers": [ "K010918" ], "product_description": "Hard shell carry case for the LIFEPAK 500 AED.", "code_info": "Cases do not contain serial numbers or lot numbers. Catalog number 3005384-000 through 002", "firm_fei_number": "3015876", "recalling_firm": "Medtronic Emergency Response Systems, Inc.", "address_1": "11811 Willows Rd Ne", "city": "Redmond", "state": "WA", "postal_code": "98052-2003", "additional_info_contact": "John A. Parks\n425-867-4681", "reason_for_recall": "Some hard shell carry case for LIFEPAK 500 and LIFEPAK CR Plus automated external defibrillators may have blocked pressure vent which may make it difficult to open the case after a sudden decrease in altitude (such as in aircraft landng or mountain descent).", "root_cause_description": "Process control", "action": "On 7/12/05 the firm issued a letter to customers instructing the customers to inspect the cases for blocked vent. If the customer noted that the vent was blocked, to contact the firm for a replacement case. The firm provided response cards for the customers to return stating they had inspected their units.", "product_quantity": "4608 cases", "distribution_pattern": "Cases were distributed nationwide and internationally.", "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" } } ] }