Teleflex Medical recalls HUDSON RCI SHERIDAN SHERI-BRONCH Endobronchial Tube REF 5-16135 - Product Usage: The Sheridan Endobronchial Tubes are i…

Recall date

October 30, 2019

Source

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

Recall number

Z-0703-2020

FDA classification

Class II

Brand / firm

Teleflex Medical

Sold / distributed

US Nationwide distribution in the states of CT, OK, LA, IL, GA, NY, CA, MT, MI, MA, FL.

Why it was recalled

The tracheal and brochial swivel connectors are incorrectly labeled.

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

What was recalled

HUDSON RCI SHERIDAN SHERI-BRONCH Endobronchial Tube REF 5-16135 - Product Usage: The Sheridan Endobronchial Tubes are intended for use in Thoracic surgery, brochospirometry, adminitration of endobronchial anesthesia and other uses commonly requiring endobronchial intubation. The Sheridan Endobronchial tube is indicated for main stem bronchus intubation and allows for selective inflation or deflation of either lung.