Recall Z-0703-2020— Teleflex Medical

Name: FDA recall Z-0703-2020
Creator: U.S. Food and Drug Administration
Published: 2019-10-30

Class II · Terminated

Class II FDA medical device recall by Teleflex Medical, initiated 2019-10-30, terminated 2021-09-30. It names one FDA 510(k) clearance: K851856. Product: 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.. Reason: The tracheal and brochial swivel connectors are incorrectly labeled..

Recalling firm: Teleflex Medical
Classification: Class II
Status: Terminated
Initiated: 2019-10-30
Terminated: 2021-09-30
Firm location: Morrisville, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K851856 — TRACHEAL/BRONCHIAL DIFFERENTIAL VENTILATION TUBESheridan Catheter Corp.·cleared 1985-05-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

The tracheal and brochial swivel connectors are incorrectly labeled.

Data sourced from openFDA. This site is unofficial and independent of the FDA.