{ "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": "124706", "product_res_number": "Z-0734-2014", "event_date_initiated": "2013-11-21", "event_date_posted": "2014-01-14", "recall_status": "Terminated", "event_date_terminated": "2014-12-11", "res_event_number": "67099", "product_code": "JTN", "k_numbers": [ "K983718" ], "product_description": "Oxoid Antimicrobial Susceptibility Testing Disc, MEM10, REF: CT0774B, 10 mcg meropenem, Packed in packs containing 5 cartridges per pack, 50 discs per cartridge. Firm name on the label is Oxoid, Ltd., Basingstoke, United Kingdom.\r\n\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 number: 1223566 EXP: 8/31/2013", "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": "Individual discs in the lot may not be sufficiently impregnated with antibiotic, resulting in smaller than expected zone sizes.", "root_cause_description": "Unknown/Undetermined by firm", "action": "Oxoid and Remel part of Thermo Fisher Scientific sent an Urgent Medical Device Recall letter dated November 20, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers.\r\n\r\nThe letter asked customers to destroy the affected product, if any was found on hand. The letter also asked if the customer further distributed the product that they inform their downstream customers. A response form was included with the letter and the letter instructed customers to complete and return the response form to indicate they had received the notification and that they had complied with it.\r\n\r\nIf you have any questions please contact our Technical Service Department at 800-255-6730 (US) or 913-888-0939 (International).", "product_quantity": "45/5/50 - discs/cartridges/packs", "distribution_pattern": "Nationwide Distribution including the states of AL, AZ, CA, CO, FL, HI, IA, IL, KY, LA, MD, MI, MN, MO, MS, NC, NY, OH, SC, TN, TX, VA, WI, and WV", "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" } } ] }