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U.S. Department of Health and Human Services

Class 2 Device Recall Enteral Feeding Tubes

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  Class 2 Device Recall Enteral Feeding Tubes see related information
Date Initiated by Firm June 04, 2018
Date Posted October 10, 2018
Recall Status1 Terminated 3 on July 21, 2020
Recall Number Z-0093-2019
Recall Event ID 81116
510(K)Number K082238  
Product Classification Tube, feeding - Product Code FPD
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.
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);              
Recalling Firm/
Manufacturer		 Neomed Inc
100 Londonderry Ct Ste 112
Woodstock GA 30188-7353
For Additional Information Contact
770-516-2225
Manufacturer 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 Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FPD and Original Applicant = NEOMED, INC.
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