Z-0093-2019Class II

NeoMed Enteral Feeding Tubes with Enteral Only Connectors, French sizes 4.0Fr, 5.0Fr, 6.5Fr, 8.0Fr, and...

Name: Z-0093-2019 NeoMed Enteral Feeding Tubes with Enteral Only Connectors, French sizes 4.0Fr, 5.0Fr, 6.5Fr, 8.0Fr, and...
Creator: Neomed Inc
Published: 2018-06-04
License: https://open.fda.gov/license/

Halyard Health / initiated 2018-06-04 / Terminated

FDA source

Neomed Inc began a recall of 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... on 2018-06-04. FDA classified it as Class II and gives the reason as "Potential for the tethered plug on the hub of the NeoMed Enteral Feeding Tubes with Enteral Only Connectors to inadvertently open after closure". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0093-2019
Classification: Class II
Status: Terminated
Initiated: 2018-06-04
Posted: 2018-10-10
Terminated: 2020-07-21
Recalling firm: Halyard Health
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.
Product code: FPD Tube, Feeding
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.
FDA 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 in commerce: 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.
Product codes and lots: 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);

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0093-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0093-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-17	2018-10-09

Product code FPD

K082238Class IINeomed Polyurethane Feeding TubeNeomed, Inc. / cleared 2008-10-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)