{ "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": "92746", "product_res_number": "Z-0160-2011", "event_date_initiated": "2010-06-25", "event_date_posted": "2010-10-28", "recall_status": "Terminated", "event_date_terminated": "2011-05-24", "res_event_number": "56148", "product_code": "DXG", "k_numbers": [ "K060660" ], "product_description": "Edwards' MHANM8 Pressure Slave Cable, Part Number:693657001\nThe Edwards Lifesciences Analog Slave Cable is used to transfer monitoring output from patient monitors to the analog input ports of the Vigileo Monitor series or compatible Edwards monitoring systems. This cable has instrument specific connectors.", "code_info": "Lot Numbers: 58822824; 58821774", "firm_fei_number": "2015691", "recalling_firm": "Edwards Lifesciences, Llc", "address_1": "1 Edwards Way", "city": "Irvine", "state": "CA", "postal_code": "92614-5688", "additional_info_contact": "949-250-2500", "reason_for_recall": "The recall was initiated because the Edwards' MHANM8 Pressure Slave Cable was wired incorrectly, thus will not work as stated.", "root_cause_description": "Process design", "action": "Edwards Lifesciences contacted customers via telephone on June 22, 2010 informing them of the product, the problem and the action they should take. Customers were asked to locate their cables and send them back overnight using the provided Edwards FedEx account number.\nEdwards Lifesciences indicated their personnel would follow-up with each customer until all units were returned.\nFor any questions regarding this recall call (949) 250-2007.", "product_quantity": "20 units", "distribution_pattern": "Worldwide Distribution - USA including CA, PA, and MI and the countries of Switzerland and Thailand", "openfda": { "k_number": [ "K844022", "K962128", "K802800", "K771718", "K771666", "K001762", "K812515", "K831967", "K842105", "K781805", "K841256", "K854371", "K896930", "K760192", "K140017", "K251275", "K833756", "K071631", "K854136", "K072735", "K134035", "K112448", "K810163", "K897004", "K813222", "K081776", "K863308", "K861092", "K872529", "K131892", "K092219", "K043103", "K073113", "K875167", "K831057", "K902628", "K863230", "K840439", "K812638", "K190955", "K253092", "K834408", "K122400", "K781535", "K913358", "K802316", "K172259", "K813020", "K822972", "K760774", "K820898", "K802305", "K812757", "K841261", "K060660", "K830628", "K772152", "K844116", "K870375", "K122121", "K940415", "K032997", "K792080", "K822877", "K790288", "K040287", "K193179", "K820194", "K852900", "K853018", "K841967", "K955417", "K023960", "K113821", "K760756", "K771924", "K822903", "K761166", "K861437", "K131048", "K760600", "K770675", "K860015", "K760844", "K790047", "K810177", "K833914", "K021874", "K103094", "K062134", "K871659", "K181372", "K862808", "K232048", "K802476", "K772158", "K870934", "K932414", "K831407", "K863231", "K820820", "K132892", "K830003", "K810170", "K080116", "K091786", "K822093", "K861505", "K152935", "K850568", "K842706", "K880258", "K943256", "K060898", "K844277", "K791753", "K811560", "K833913", "K884122", "K122247", "K896528", "K781855", "K833395", "K961661", "K894234", "K880301", "K132528", "K100709", "K840009", "K970784", "K811062", "K212529", "K812971", "K843555", "K770330", "K880696", "K946115", "K131588", "K101487", "K110597", "K862261", "K791756", "K844682", "K811414", "K834059", "K893392", "K010049", "K991775", "K884619", "K771991", "K863153", "K895017", "K832644", "K841401", "K842831", "K770179", "K962918", "K802198", "K810851", "K922218", "K134051", "K812932", "K844997", "K901926", "K830892", "K844665", "K760532", "K082308", "K000664", "K865101", "K813223", "K042144", "K192169", "K883855", "K792678", "K163334", "K861543" ], "registration_number": [ "3012536737", "2648045", "3004519921", "3009001657", "9610816", "3021242837", "1319030", "3011353843", "3013319763", "3009077524", "8020616", "3015418961", "3005783425", "2133641", "9617127", "3005877899", "3010157426", "3008716327", "2221819", "3003617485", "1218950", "3008729547", "3013679558", "3033589330", "1651104", "3003263092", "3013783488", "1416980", "3015173212", "3010698831", "3005580113", "3010170586", "9710602", "1018233", "3016701404", "3009156722", "3012528160", "9681377", "3013596024", "3004832480", "3014541700", "3008483389", "3016618143", "3005770916", "3015455735", "3032916632", "2243374", "3006082230", "8010042", "9615817", "3015309643", "3007603826", "3008403546", "3013500228", "3007836437", "3000126629", "3006950086", "3004415095", "3008132398", "9610105", "3016585366", "1720929", "3005004021" ], "fei_number": [ "3012536737", "2648045", "3009001657", "3021242837", "3002808128", "1319030", "3011353843", "3013319763", "3009077524", "3002806476", "3015418961", "3005783425", "3003081151", "3005877899", "3010157426", "3008716327", "1000300598", "3003617485", "1000122327", "2221819", "1218950", "3008729547", "3013679558", "3033589330", "3003263092", "3001139253", "3013783488", "1416980", "3015173212", "3010698831", "3005580113", "3010170586", "1018233", "3003513129", "3016701404", "3009156722", "3002806783", "3012528160", "3013596024", "3004832480", "3014541700", "3005846326", "3008483389", "3016618143", "3005770916", "3015455735", "3032916632", "3006082230", "3002807091", "3002737156", "3008403546", "3013500228", "3015309643", "3007603826", "3007836437", "3000126629", "3006950086", "3004415095", "3002807167", "3016585366", "3000203466", "1720929", "3005004021" ], "device_name": "Computer, Diagnostic, Pre-Programmed, Single-Function", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.1435", "device_class": "2" } } ] }