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NeoMed Enteral Feeding Tubes with Enteral Only Connectors… recallZ-0093-2019 · Neomed Inc · initiated Jun 4, 2018

Class II Terminated All recalls posted in October 2018

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Neomed Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 category: Other

What the company is doing

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.

Recall details

Recall number
Z-0093-2019
Recall class
Class II
Status
Terminated
Initiated by the company
Jun 4, 2018
Posted by the FDA
Oct 10, 2018
Recalling firm
Neomed Inc
Quantity
208,260 units (20,826 cases)
Product code
FPD
FDA submissions
K082238
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 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. 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.

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

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);

Other devices under the same FDA submission

23 devices cleared under K082238 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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