{ "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": 15 } }, "results": [ { "cfres_id": "183811", "product_res_number": "Z-0100-2021", "event_date_initiated": "2020-09-08", "event_date_created": "2020-10-13", "recall_status": "Terminated", "event_date_terminated": "2021-01-11", "res_event_number": "86479", "product_code": "MQL", "k_numbers": [ "K100367" ], "product_description": "MediCult Vitrification Cooling Media, Model Number 12284001F", "code_info": "Lot: 20230080", "firm_fei_number": "1216677", "recalling_firm": "CooperSurgical, Inc.", "address_1": "95 Corporate Dr", "city": "Trumbull", "state": "CT", "postal_code": "06611-1350", "additional_info_contact": "203-601-9818", "reason_for_recall": "There is a discrepancy between the printing on the Product Tyvek label of the individual component packaging. The Chinese characters on the label indicates that it contains an Equilibration Medium (P/N: 12220001) rather than the Vitrification Medium (P/N: 12230001) as indicated on the remainder of the label.", "root_cause_description": "Under Investigation by firm", "action": "URGENT: MEDICAL DEVICE FIELD SAFETY NOTICE letters dated 9/8/20 were sent to customers.\n\nOur records indicate that you have purchased the affected Product from CooperSurgical. The affected Vitrification Medium Product is of the correct formulation and functionally acceptable per quality release specifications and will work as intended in accordance with the accompanying Instructions For Use.\n\nPlease discontinue use of and quarantine the Products, complete the attached Acknowledgement and Receipt Form, and return it to CooperSurgical. Once we receive the Acknowledgement Form, we will arrange for Product replacements and returns of affected Product. The replacement Products will be charged at the same price as the original order and your account will be credited back once the affected Products are returned to CooperSurgical. If you do not have affected Product in inventory, please use the same enclosed Form to indicate that and return it to CooperSurgical so that we may document receipt of this Field Safety Notice.\n\nThe Chinese Food and Drug Administration has been notified of this Field Safety Notice. We sincerely apologize for any inconvenience caused by this Field Safety Notice. CooperSurgical is committed to high quality, safe and effective products. Please feel free to reach us at +001.203.601.5200 ext. 3300.", "product_quantity": "531 total boxes", "distribution_pattern": "The products were distributed to China.", "openfda": { "k_number": [ "K000618", "K011462", "K171224", "K053551", "K991338", "K022335", "K173731", "K232942", "K002623", "K000939", "K991419", "K002630", "K003278", "K022334", "K991346", "K023106", "K001967", "K121128", "K182002", "K991396", "K112083", "K022330", "K991022", "K233846", "K991348", "K991337", "K040530", "K000938", "K000940", "K072608", "K991329", "K991339", "K022247", "K002383", "K241095", "K991335", "K170681", "K223265", "K000627", "K023850", "K080473", "K020490", "K021896", "K991472", "K991334", "K120136", "K152932", "K000989", "K172197", "K081639", "K983588", "K072607", "K000623", "K023717", "K991351", "K991379", "K250445", "K003734", "K991420", "K024290", "K160863", "K030490", "K991390", "K002836", "K030117", "K012123", "K991331", "K251637", "K023403", "K000937", "K160814", "K001113", "K242089", "K002385", "K160864", "K991391", "K092963", "K092667", "K013518", "K093273", "K011573", "K213293", "K171748", "K991395", "K060983", "K991332", "K082363", "K022590", "K991393", "K070135", "K251305", "K092578", "K101003", "K222606", "K242107", "K242043", "K033101", "K183486", "K220715", "K991345", "K991322", "K060699", "K170257", "K030116", "K081117", "K022547", "K233764", "K000626", "K971809", "K152440", "K240605", "K081115", "K061309", "K984172", "K010183", "K234023", "K031228", "K053646", "K983589", "K200408", "K061145", "K983586", "K153290", "K003404", "K143724", "K061371", "K991470", "K042495", "K092107", "K153478", "K140317", "K011938", "K200680", "K991327", "K143498", "K991380", "K023222", "K000309", "K031304", "K011481", "K152904", "K170498", "K980814", "K200249", "K991381", "K241132", "K191063", "K152717", "K032877", "K022002", "K083509", "K031486", "K053552", "K032155", "K180073", "K241833", "K031015", "K193522", "K003448", "K233477", "K011606", "K152682", "K190152", "K983579", "K030850", "K161261", "K162409", "K133387", "K991343", "K022244", "K193285", "K212410", "K053494", "K983580", "K202862", "K011346", "K242640", "K100367", "K153267", "K991279", "K242968", "K073522", "K022931", "K023033", "K081114", "K003156", "K000619", "K022332", "K991378", "K133707", "K081116", "K080446", "K170602", "K991173", "K252672", "K991471", "K032887", "K070689", "K121572", "K152782", "K022443", "K192503", "K021894", "K133912", "K192644", "K160006", "K991342", "K011607", "K080172", "K993484", "K023206", "K170560", "K212426", "K033462", "K072609", "K991341", "K021893", "K003163", "K150950", "K142991", "K190199", "K021890", "K160142", "K000621", "K240149", "K190383", "K022245", "K133568", "K032154", "K113786", "K030441", "K242561", "K021358", "K232125", "K000625", "K191552", "K991330", "K003751", "K991333", "K041284", "K231370", "K151367", "K022295", "K043116", "K223117", "K023655", "K240176", "K034063", "K011157", "K260248", "K060168", "K023353", "K983584", "K864524", "K991392", "K022352", "K173624", "K192845", "K991421" ], "registration_number": [ "3030390242", "3021166069", "3004882774", "3025773437", "3036725842", "3003274090", "3012853704", "3033813683", "3015140190", "3003272500", "3017896194", "3005580113", "3003766921", "3016126174", "3008876063", "3036495174", "3018010054", "2031824", "1221433", "3004048494", "9616005", "3007800906", "3007738736", "3014295858", "1222779", "1216677", "3010413864", "3014755376", "3003995932", "3030681110" ], "fei_number": [ "3030390242", "3021166069", "3004882774", "3025773437", "3036725842", "1000120774", "3003274090", "3012853704", "3033813683", "3015140190", "3003272500", "3004848623", "3017896194", "3005580113", "3003766921", "3016126174", "3008876063", "3036495174", "3018010054", "1221433", "3002757762", "3004048494", "3007800906", "3007738736", "3014295858", "1216677", "3010413864", "3014755376", "3003995932", "3030681110" ], "device_name": "Media, Reproductive", "medical_specialty_description": "Obstetrics/Gynecology", "regulation_number": "884.6180", "device_class": "2" } } ] }