DeRoyal Industries Inc recalls DeRoyal Enteral Safe Feeding Tubes: a) REF 54-2450R, 5 FR x 24" Polyurethane b) REF 54-2465R, 6.5 FR x 24" Polyurethane…

Recall date

July 22, 2019

Source

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

Recall number

Z-2293-2019

FDA classification

Class II

Brand / firm

DeRoyal Industries Inc

Sold / distributed

US Nationwide Distribution in the states of N, TX, IL OH, NM, UT. NB, KY, CO

Why it was recalled

Certain MED-RX Polyurethane Feeding Tubes are being recalled due to a product concern where the connector has detached from the feeding tube.

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

What was recalled

DeRoyal Enteral Safe Feeding Tubes: a) REF 54-2450R, 5 FR x 24" Polyurethane b) REF 54-2465R, 6.5 FR x 24" Polyurethane c) REF 54-2480R, 8 FR x 24" Polyurethane d) REF 54-3680R, 8 FR x 36" Polyurethane Product Usage: Feeding tube