Reported Oct 17, 2018 · Terminated

NeoMed Enteral Feeding Tubes with Enteral Only Connectors, French sizes 4.0Fr, 5.0Fr, 6.5Fr, 8.0Fr, and lengths 40cm,…

Neomed Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Neomed Inc · 100 Londonderry Ct Ste 112 · Woodstock, GA · 30188-7353

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 UsageIntended 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

Lot codes and dates: 14 of 14 products
Products covered by this recall
# Product as published
1 Model Number (Lot Numbers): FTS5.0P EO (20170731, 20170804, 20170813, 20170914, 20171011, 20171018, 20171128, 20180108, 20180125)
2 FTM5.0P EO (20170818, 20170904, 20170915, 20171009, 20171130, 20171204, 20171227, 20180205, 20180317)
3 FTL5.0P EO (20170816, 20170904, 20171204, 20180115)
4 FTS6.5P EO (20170830, 20170918, 20171019, 20171122, 20171214, 20171216, 20180122, 20180208, 20181113)
5 FTM6.5P EO (20170906, 20171020, 20171202, 20171219, 20180111, 20180208, 20180303, 20180320)
6 FTL6.5P EO (20170708, 20171209, 20180113, 20180122, 20180309, 20180323)
7 FTS8.0P EO (20170825, 20171207, 20171230, 20180103, 20180325)
8 FTM8.0P EO (20171115, 20171222, 20180129)
9 FTL8.0P EO (20170719, 20170721, 20171114, 20180116, 20180202, 20180422)
10 PFTL5.0P EO (20171124)
11 PFTM6.5P EO (20171121)
12 PFTL6.5P EO (20170819, 20171120)
13 PFTM8.0P EO (20170906, 20170919, 20171116)
14 PFTL8.0P EO (20170919, 20171006, 20171118)
Amount recalled: 208,260 units (20,826 cases)

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

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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#	Product as published
1	Model Number (Lot Numbers): FTS5.0P EO (20170731, 20170804, 20170813, 20170914, 20171011, 20171018, 20171128, 20180108, 20180125)
2	FTM5.0P EO (20170818, 20170904, 20170915, 20171009, 20171130, 20171204, 20171227, 20180205, 20180317)
3	FTL5.0P EO (20170816, 20170904, 20171204, 20180115)
4	FTS6.5P EO (20170830, 20170918, 20171019, 20171122, 20171214, 20171216, 20180122, 20180208, 20181113)
5	FTM6.5P EO (20170906, 20171020, 20171202, 20171219, 20180111, 20180208, 20180303, 20180320)
6	FTL6.5P EO (20170708, 20171209, 20180113, 20180122, 20180309, 20180323)
7	FTS8.0P EO (20170825, 20171207, 20171230, 20180103, 20180325)
8	FTM8.0P EO (20171115, 20171222, 20180129)
9	FTL8.0P EO (20170719, 20170721, 20171114, 20180116, 20180202, 20180422)
10	PFTL5.0P EO (20171124)
11	PFTM6.5P EO (20171121)
12	PFTL6.5P EO (20170819, 20171120)
13	PFTM8.0P EO (20170906, 20170919, 20171116)
14	PFTL8.0P EO (20170919, 20171006, 20171118)