{ "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": "118156", "product_res_number": "Z-0792-2014", "event_date_initiated": "2013-04-09", "event_date_posted": "2014-01-21", "recall_status": "Terminated", "event_date_terminated": "2014-01-21", "res_event_number": "65184", "product_code": "JTN", "k_numbers": [ "K973487" ], "product_description": "Oxoid Antimicrobial Susceptibility Test Discs, Cefpodoxime 10 mcg., CT1612B, packaged in cartridges of 50 discs, 5 cartridges/pack. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England.\r\nUsed in the semi-quantitative agar diffusion test method for in-vitro susceptibility testing to assist in the determination of a suitable antibiotic agent for treatment purposes", "code_info": "Lot 1275353, Exp. 31Dec2015", "firm_fei_number": "1924669", "recalling_firm": "Remel Inc", "address_1": "12076 Santa Fe Trail Dr", "city": "Lenexa", "state": "KS", "postal_code": "66215-3519", "additional_info_contact": "Earleen C. Parks\n913-895-4185", "reason_for_recall": "Cartridges may contain individual discs which were not impregnated with antibiotic.", "root_cause_description": "Process design", "action": "ThermoFisher Scientific sent a Medical Device Recall letter dated March 22, 2013, to affected customers. Letters dated April 9, 2013, were issued for the remaining three products. Customers were instructed to notify all personnel who need to be notified and review their inventory and discard any affected product. Customers were also instructed to return the attaced Medical Device Recall Response acknowleding the dispoasl of the affected product. Customers with questions were instructed to contact the Technical Services Department at 800-255-6730 or 913-888-0939 (International).\r\nFor questions regarding this recall call 913-895-4185.", "product_quantity": "9 packs", "distribution_pattern": "Nationwide Distribution: US including Puerto Rico.", "openfda": { "k_number": [ "K003690", "K984608", "K250789", "K970831", "K850357", "K860527", "K992297", "K182357", "K843725", "K833414", "K871674", "K994135", "K812844", "K973488", "K020842", "K011086", "K982520", "K923952", "K870201", "K964496", "K892720", "K000302", "K983718", "K971635", "K810564", "K933118", "K000928", "K982526", "K810427", "K833709", "K152838", "K003556", "K042157", "K892721", "K833415", "K984513", "K855135", "K822394", "K872783", "K260842", "K171975", "K001487", "K893754", "K852967", "K994067", "K231568", "K970385", "K864756", "K103538", "K892717", "K000524", "K890344", "K221826", "K922794", "K993993", "K920131", "K971638", "K000130", "K812993", "K000175", "K802178", "K930946", "K801473", "K813441", "K860536", "K002661", "K963845", "K052876", "K080998", "K892730", "K821229", "K994051", "K821264", "K010536", "K070262", "K992420", "K842253", "K930702", "K261853", "K931289", "K910412", "K982528", "K971632", "K812228", "K210873", "K002368", "K993994", "K001490", "K000201", "K261781", "K870870", "K892722", "K924766", "K181700", "K831153", "K843172", "K183298", "K011385", "K980955", "K971637", "K812994", "K892719", "K832956", "K000268", "K855206", "K000440", "K984036", "K982235", "K192326", "K992507", "K832910", "K860153", "K170127", "K970212", "K992076", "K852835", "K842292", "K002664", "K964490", "K892725", "K994132", "K000829", "K250454", "K993577", "K992726", "K924846", "K971633", "K830956", "K931799", "K000525", "K892715", "K830731", "K873707", "K892723", "K964489", "K973489", "K922791", "K232276", "K000271", "K852689", "K935975", "K892724", "K872938", "K992717", "K972098", "K892735", "K000526", "K810546", "K001489", "K955669", "K250885", "K850606", "K902082", "K964512", "K931290", "K230827", "K000930", "K850607", "K002662", "K921282", "K865034", "K812524", "K870347", "K003554", "K251879", "K052853", "K000509", "K203336", "K821262", "K980683", "K964487", "K181975", "K982519", "K994063", "K973479", "K943407", "K982669", "K812525", "K964495", "K193504", "K921420", "K961818", "K831179", "K982517", "K002656", "K000261", "K931530", "K933657", "K944275", "K992647", "K832515", "K152516", "K002367", "K934100", "K812571", "K974394", "K082271", "K172621", "K833416", "K000305", "K892728", "K892726", "K230651", "K994129", "K842307", "K000128", "K920473", "K811377", "K992646", "K813387", "K994091", "K191931", "K050062", "K964493", "K994150", "K001728", "K000181", "K940359", "K924797", "K852873", "K982524", "K895392", "K994212", "K992077", "K000272", "K082272", "K002165", "K820019", "K910506", "K992853", "K925969", "K203700", "K062245", "K000182", "K994046", "K965159", "K964492", "K892714", "K892733", "K851228", "K924765", "K864848", "K152846", "K812783", "K100722", "K250956", "K801474", "K812916", "K964491", "K973487", "K842252", "K003536", "K241060", "K994089", "K000203", "K000762", "K891772", "K892729", "K870175", "K093807", "K112586", "K060286", "K971631", "K832909", "K992568", "K002660", "K922793", "K992593", "K930911", "K850358", "K003537", "K874425", "K964421", "K925060", "K992546", "K982523", "K993186", "K971120", "K830732", "K992562", "K231806", "K801648", "K870348", "K253105", "K002369", "K002663", "K003532", "K971636", "K251337", "K892713", "K850957", "K894829", "K981517", "K802194", "K920787", "K874256", "K860895", "K080019", "K823800", "K895679", "K010537", "K873829", "K822832", "K000258", "K822809", "K963508", "K760701", "K000183", "K920786", "K961188", "K832653", "K921193", "K994134", "K000022", "K961819", "K851622", "K900344", "K011384", "K974578", "K003686", "K892727", "K932052", "K892718", "K964501", "K970830", "K193508", "K971211", "K000259", "K800540", "K000304" ], "pma_number": [ "N60242" ], "registration_number": [ "2032112", "3013661582", "3012389632", "2647876", "1119779", "3004111573", "2030652", "3035367039", "2022807", "8010096", "8020667" ], "fei_number": [ "3000205059", "3013661582", "4247", "3012389632", "3006224287", "2647876", "3003076831", "1119779", "3004111573", "3035367039", "2022807" ], "device_name": "Susceptibility Test Discs, Antimicrobial", "medical_specialty_description": "Microbiology", "regulation_number": "866.1620", "device_class": "2" } } ] }