Neomed Inc recalls NeoMed Enteral Feeding Tubes with Enteral Only Connectors, French sizes 4.0Fr, 5.0Fr, 6.5Fr, 8.0Fr, and lengths 40cm, 6…

Recall date

June 4, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0093-2019

FDA classification

Class II

Brand / firm

Neomed Inc

Sold / distributed

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, Nebrask…

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.