{ "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": "183906", "product_res_number": "Z-0456-2021", "event_date_initiated": "2020-09-16", "event_date_created": "2020-11-16", "recall_status": "Terminated", "event_date_terminated": "2021-06-01", "res_event_number": "86522", "product_code": "JSM", "product_description": "Merit Medical Cultura Collection and Transport System, 3 mL Viral Transport Medium, Ref: VCTS100, Single Use, IVD, for the following unit counts: 1 Unit - (01)00884450499917, 50 Units - (01)10884450499914, 200 units - (01)20884450499911", "code_info": "All Lots distributed prior to August 28, 2020. 1 Unit - (01)00884450499917, 50 Units - (01)10884450499914, 200 units - (01)20884450499911", "firm_fei_number": "1721504", "recalling_firm": "Merit Medical Systems, Inc.", "address_1": "1600 W Merit Pkwy", "city": "South Jordan", "state": "UT", "postal_code": "84095-2416", "additional_info_contact": "Cory Marsh\n801-316-3690", "reason_for_recall": "The flocked tip of the 100mm swab may break off in the nasophyaryngeal cavity during sample collection. This could result in soft tissue injury of the nasophyaryngeal cavity or a delay in treatment.", "root_cause_description": "Device Design", "action": "The firm sent an recall notification on September 16, 2020 to all affected consignees. In addition to informing consignees about the correction, the firm requested consignees take the following action:\n\n1. Please refer to the attached instructions and/or linked instructional video when collecting samples with nasopharyngeal swabs.\n2. Ensure that applicable personnel within your organization are made aware of this notice.\n3. If the product has been further distributed to other facilities, institutions, or manufacturers, please ensure this notice is immediately shared with them.\n4. If you have any questions or concerns regarding this communication or the products addressed, please contact your Merit Sales Representative or Merit Customer Service at (801) 208-4381.", "product_quantity": "371,528 units", "distribution_pattern": "Worldwide distribution. US Nationwide, Australia, Canada, Colombia, Ghana, Ireland, Jamaica, Kenya, Panama, Qatar, Trinidad and Tobago.", "openfda": { "k_number": [ "K791543", "K142366", "K141506", "K242576", "K242976", "K211256", "K032246", "K042970", "K792712", "K881539", "K800832", "K150887", "K863527", "K180052", "K872213", "K162284", "K860657", "K965149", "K220908", "K943498", "K844369", "K931922", "K972726", "K955451", "K910180", "K871404", "K946283", "K885244", "K113249", "K935987", "K834125", "K231027", "K961046", "K160082", "K864237", "K212856", "K941579", "K831159", "K232357", "K946286", "K962843", "K935618", "K946284", "K932337", "K240235", "K791545", "K791514", "K921472", "K854715", "K965151", "K936078", "K864998", "K231843", "K946288", "K964637", "K834316", "K212743", "K834315", "K163436", "K861080", "K211707", "K024240", "K965150", "K850717", "K791515", "K860178", "K885245", "K970597", "K863164", "K965152", "K872507", "K863602", "K024237", "K946287", "K881105", "K844747", "K844370", "K881529", "K220739", "K220052", "K854061", "K233449", "K871065", "K910526", "K202531", "K881569", "K854986", "K946285", "K914894", "K250205", "K841205", "K142094", "K913789", "K232565", "K860656", "K850124", "K860658", "K233534", "K001780", "K853500", "K201674", "K822886", "K823179", "K230035", "K863682", "K844634", "K993812", "K232454", "K943499", "K831059", "K802303" ], "device_name": "Culture Media, Non-Propagating Transport", "medical_specialty_description": "Microbiology", "regulation_number": "866.2390", "device_class": "1", "registration_number": [ "3027519599", "9617475", "3013188547", "3014150341", "1216735", "3009547954", "1917413", "1318354", "3018348", "3012494290", "1924669", "1720929", "3017063217", "9610649", "3024463179", "3036773433", "3035375122", "3001124136", "3005739529", "3013245669", "3006198300", "1417592", "3016837106", "3005182159", "2243072", "9681465", "3011689956", "1063851", "3010600155", "3002444944", "2436875", "3016741564", "3010132111", "3009613136", "3014588186", "1043646", "3009963993", "2013736", "3000268902", "9681576", "2183744", "8020040", "1319639", "1524213", "3003750284", "9613662", "3011649813", "3015505238", "3016838963", "2022807", "1220477", "3010407203", "3013661582", "3017830316", "9680143", "3009732568", "3012389632", "3015441043", "3015173212", "3010420046", "3013557562", "3015376545", "3014662855", "3004122598", "3012073813", "3004530258", "3043127647", "8020315", "3017231634", "3003207991", "3018779125", "3016587486", "3008132411" ], "fei_number": [ "3027519599", "1000138054", "3013188547", "3002807578", "3014150341", "1216735", "3009547954", "1917413", "1318354", "3018348", "3012494290", "1924669", "1720929", "3017063217", "3024463179", "3002808075", "3036773433", "3002807308", "3035375122", "3001124136", "3005739529", "3013245669", "3006198300", "5804", "1417592", "3000974732", "1000521444", "3016837106", "3005182159", "2243072", "3011689956", "3010600155", "3002546385", "3002444944", "3016741564", "3010132111", "3009613136", "3014588186", "3002919051", "1043646", "3009963993", "2013736", "3000268902", "2183744", "1524213", "3003750284", "3011649813", "3002807113", "3015505238", "3016838963", "2022807", "1220477", "3010407203", "3013661582", "3017830316", "3009732568", "3012389632", "3015441043", "3015173212", "3010420046", "3013557562", "3015376545", "3014662855", "3004122598", "3012073813", "3004530258", "1000442352", "3043127647", "3017231634", "3003207991", "3018779125", "3016587486", "3008132411" ] } } ] }