{ "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": "112581", "product_res_number": "Z-0165-2013", "event_date_initiated": "2012-07-25", "event_date_posted": "2012-10-29", "recall_status": "Terminated", "event_date_terminated": "2013-12-17", "res_event_number": "63112", "product_code": "LDF", "k_numbers": [ "K831695" ], "product_description": "Myocardial Heart Wires\n\nIntended for temporary atrial and ventricular pacing and sensing during or after cardiac surgery in conjunction with an external pulse generator.", "code_info": "Model Number TME60S, Lot #C1-07101 Model Number TME64S, Lot #C1-07056 Model Number TME64S, Lot #C1-07057 Model Number TME64S, Lot #C1-07058 Model Number TME64S, Lot #C1-07111 Model Number TME64S, Lot #C1-07112 Model Number TME64S, Lot #C1-07113 Model Number TME64S, Lot #C1-07114 Model Number TME64S, Lot #C1-07122 Model Number TME64S, Lot #C1-07123 Model Number TME64S, Lot #C1-07124 Model Number TME64S, Lot #C1-07125 Model Number TME64C, Lot #C1-07143 Model Number TME64S, Lot #C1-07151 Model Number TME64S-3, Lot #C1-07156 Model Number TME65S, Lot #C1-07174", "firm_fei_number": "1035166", "recalling_firm": "Oscor, Inc.", "address_1": "3816 Desoto Boulevard", "city": "Palm Harbor", "state": "FL", "postal_code": "34683-1618", "additional_info_contact": "Mila Doskocil\n727-937-2511 Ext. 133", "reason_for_recall": "Oscor, Inc. in Palm Harbor, FL is recalling myocardial heart wires, models TME60S, TME64S, TME64C, TME64S-3, TME65S, and TME66S. The recall was initiated due to the spacing between anchoring zig-zag to electrode is out of specification.", "root_cause_description": "Process control", "action": "Oscor sent a customer notification letter dated July 25, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to send the listed models and lots in their inventory back to the recalling firm for immediate replacement. They were also instructed to call Oscor Customer Service at 727-937-2511 to obtain a Return Goods Product (RGA) number.\nFor questions regarding this recall call 727-937-2511, ext. 133.", "product_quantity": "1425", "distribution_pattern": "Worldwide Distribution - USA including OR, FL, Al, TX, NM, CA, AL, PA, KY, IN, OH, and IL and internationally to Canada, Russia, and New Zealand", "openfda": { "k_number": [ "K012458", "K861403", "K862970", "K012452", "K242863", "K023174", "K954809", "K873728", "K922268", "K173923", "K934785", "K843141", "K190716", "K861409", "K902342", "K844003", "K851913", "K011660", "K875059", "K973360", "K241334", "K232261", "K033858", "K852513", "K882330", "K812725", "K822002", "K821518", "K813521", "K803086", "K831695", "K831804", "K040812", "K881356", "K962467", "K813138", "K963073", "K152784", "K812781", "K980503", "K810312", "K962833", "K851845", "K900982", "K961520", "K012459", "K874310", "K161249", "K890988", "K960479", "K924388", "K971775", "K930069", "K855139", "K853818", "K812517", "K810041", "K171253", "K811318", "K800298", "K944957", "K841802", "K042190", "K955722", "K843290", "K010099", "K152633", "K922182", "K850622", "K032613", "K913521", "K831645", "K802259", "K834416", "K801800", "K820232", "K872972", "K934787", "K914185", "K803058", "K922269", "K852797", "K830094", "K864507", "K160260", "K944956", "K822003", "K140972", "K781002", "K012460", "K904868", "K822155", "K030556", "K944966", "K812307", "K002603", "K851246", "K840109", "K890794", "K810642", "K830772", "K924390", "K161873", "K242705", "K241199", "K850324", "K895789", "K971165", "K873474", "K832850", "K002687", "K955829", "K873716", "K791183", "K955712", "K252042", "K012454", "K884866", "K820003", "K821333", "K882045", "K072770", "K810657", "K832561", "K923407", "K801799", "K002481", "K251186", "K963898", "K810643" ], "registration_number": [ "3015859709", "3007770159", "", "2011171", "2134812", "3008061490", "1018233", "2210968", "2024311", "1721686", "3018094310", "2648045", "9673241", "3035372913", "3013288201", "3033589330", "3012179728", "3012536737", "2032112", "1313046", "1317547", "2182208", "3015309643", "3004365956", "3017102971", "3032916632", "3006082230", "1043214", "1721504", "2025587", "3015225571", "3008496528", "3013162291", "3017060084", "1721676", "1928237", "2024168", "2184009", "3004091615", "1319639", "3006950086", "3003955307", "3003923762", "9611350", "2939561", "3017896194", "3035111606", "1035166", "8043983", "2648623", "3027815", "1018470", "3010041511", "1450662", "3004785273", "9611665", "3011163668", "3011137372", "1061124", "1061927", "3015173212", "3005012805", "2242056", "1650907", "3010532612", "3014255018", "2135338", "3006638824", "2648650" ], "fei_number": [ "3000203000", "3007770159", "3015859709", "", "1000116158", "3005700659", "1000138054", "2011171", "3008061490", "3005747797", "3003076831", "1018233", "2210968", "2024311", "1721686", "3018094310", "2648045", "3035372913", "3013288201", "3033589330", "3012179728", "3012536737", "1313046", "1317547", "1000127185", "2182208", "3015309643", "3004365956", "3017102971", "3032916632", "3006082230", "1043214", "1721504", "2025587", "3002827704", "3008496528", "3015225571", "3013162291", "3017060084", "1721676", "1928237", "3016261803", "2024168", "3004091615", "3006950086", "3003955307", "3003923762", "1000512168", "3017896194", "3035111606", "1035166", "3003248396", "2648623", "1018470", "3002807095", "3010041511", "3004635528", "3004785273", "3011163668", "1450662", "3015173212", "3002681132", "3005012805", "1000241540", "2242056", "3010532612", "3014255018", "3006638824", "2648650" ], "device_name": "Electrode, Pacemaker, Temporary", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.3680", "device_class": "2" } } ] }