Neomed Inc: 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.

Recall number

Z-0093-2019

Recalling firm

Neomed Inc

Product

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.

Status

Terminated

Initiated

2018-06-04

Posted

2018-10-10

Terminated

2020-07-21

Reason

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

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. Questions can be directed to NeoMed at 888-876-2225.

Quantity

208,260 units (20,826 cases)

Distribution

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.

Lot, serial or model codes

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);

510(k) numbers

["K082238"]

PMA numbers

not on file

Product code

FPD

Firm FEI

3011270181

Firm city

Woodstock

Firm state

GA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy