{ "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": 1 } }, "results": [ { "cfres_id": "167477", "product_res_number": "Z-0093-2019", "event_date_initiated": "2018-06-04", "event_date_posted": "2018-10-10", "recall_status": "Terminated", "event_date_terminated": "2020-07-21", "res_event_number": "81116", "product_code": "FPD", "k_numbers": [ "K082238" ], "product_description": "NeoMed Enteral Feeding Tubes with Enteral Only Connectors, French sizes 4.0Fr, 5.0Fr, 6.5Fr, 8.0Fr, and lengths 40cm, 60cm, 90cm. The product consists of a polyurethane feeding tube with an attached hub and tethered plug to close the hub when the feeding tube is not in use.\n\nProduct Usage:\nIntended for use in neonatal and pediatric patients to provide nutrition via nasal or oral gastric placement and is not intended for use beyond 30 days.", "code_info": "Model Number (Lot Numbers):  FTS5.0P EO (20170731, 20170804, 20170813, 20170914, 20171011, 20171018, 20171128, 20180108, 20180125);   FTM5.0P EO (20170818, 20170904, 20170915, 20171009, 20171130, 20171204, 20171227, 20180205, 20180317);   FTL5.0P EO (20170816, 20170904, 20171204, 20180115);   FTS6.5P EO (20170830, 20170918, 20171019, 20171122, 20171214, 20171216, 20180122, 20180208, 20181113);   FTM6.5P EO (20170906, 20171020, 20171202, 20171219, 20180111, 20180208, 20180303, 20180320);   FTL6.5P EO (20170708, 20171209, 20180113, 20180122, 20180309, 20180323);   FTS8.0P EO (20170825, 20171207, 20171230, 20180103, 20180325);   FTM8.0P EO (20171115, 20171222, 20180129);   FTL8.0P EO (20170719, 20170721, 20171114, 20180116, 20180202, 20180422);   PFTL5.0P EO (20171124);   PFTM6.5P EO (20171121);   PFTL6.5P EO (20170819, 20171120);   PFTM8.0P EO (20170906, 20170919, 20171116);   PFTL8.0P EO (20170919, 20171006, 20171118);", "firm_fei_number": "3011270181", "recalling_firm": "Neomed Inc", "address_1": "100 Londonderry Ct Ste 112 100 Londonderry Ct", "address_2": "Ste 112", "city": "Woodstock", "state": "GA", "postal_code": "30188-7353", "additional_info_contact": "770-516-2225", "reason_for_recall": "Potential for the tethered plug on the hub of the NeoMed Enteral Feeding Tubes with Enteral Only Connectors to inadvertently open after closure.", "root_cause_description": "Other", "action": "On about 06/04/2018, NeoMed notified customers via \"URGENT: MEDICAL DEVICE RECALL.\" Instructions included to examine inventory for affected devices, notify customers if the devices have been further distributed, complete and return the Response Form, and arrange for the return of all affected devices to NeoMed. \n\nQuestions can be directed to NeoMed at 888-876-2225.", "product_quantity": "208,260 units (20,826 cases)", "distribution_pattern": "Worldwide Distribution - US Nationwide in the states of: Alaska, Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, and Wyoming. \n\nWorldwide distribution to Australia, Canada, Singapore, and Spain.", "openfda": { "k_number": [ "K915438", "K060944", "K083776", "K890116", "K896734", "K896559", "K770620", "K890396", "K101214", "K895824", "K780415", "K894939", "K072831", "K981629", "K905677", "K901163", "K915439", "K897181", "K913701", "K914492", "K100163", "K243361", "K884415", "K912575", "K760137", "K083786", "K915308", "K072881", "K954218", "K003311", "K895923", "K100700", "K180236", "K862090", "K912972", "K914482", "K963779", "K892431", "K100526", "K100099", "K913407", "K810131", "K082238", "K870623", "K120815", "K110853", "K781385", "K953008", "K091340", "K071191", "K972437", "K971906", "K852100", "K894860", "K131590", "K083210", "K121105", "K083791", "K922402" ], "device_name": "Tube, Feeding", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.5980", "device_class": "2", "registration_number": [ "3009888344", "3003627840", "3004569180", "3012494290", "1220477", "2245270", "3008806809", "3014663754", "3007084575", "3018094310", "8030107", "2080225", "3006795797", "2011171", "1055236", "3011987967", "3011270181", "3010331226", "3002808467", "1043214", "3011137372", "3014421917", "3005483737", "3003681915", "9611594", "1054241", "1060680", "1643817", "1221765", "3010041511", "3011237770", "8022210", "3007138831", "2936999", "3005099803", "8020785", "3010131137", "2029015", "2528981", "1422634", "1223004", "3009698186", "3009291251", "9681384", "3004365956", "9611665", "3008311916" ], "fei_number": [ "3009888344", "3003627840", "3004569180", "3012494290", "1220477", "2245270", "3008806809", "3014663754", "1000160458", "3007084575", "3018094310", "2080225", "3006795797", "2011171", "7682", "3011987967", "3011270181", "3010331226", "3002808467", "1043214", "1000208624", "1000112968", "3014421917", "1000514656", "3005483737", "3003681915", "3932", "1643817", "1221765", "1000120555", "3010041511", "3011237770", "3002807626", "3007138831", "2936999", "3002806436", "3005099803", "3010131137", "2528981", "3005747797", "3002807095", "3009698186", "3009291251", "3004365956", "1000112877", "3008311916" ] } } ] }