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. Product Usage: Intended 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.

Reason: Potential for the tethered plug on the hub of the NeoMed Enteral Feeding Tubes with Enteral Only Connectors to inadvertently open after closure.

Code information: 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);

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. Worldwide distribution to Australia, Canada, Singapore, and Spain.