Events

Recall of Device Recall Hudson RCI/Novaplus Sheridan SherIBronch Left Endobronchial Tube

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Teleflex Medical.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    31205
  • Event Risk Class
    Class 2
  • Event Number
    Z-0680-05
  • Event Initiated Date
    2005-02-23
  • Event Date Posted
    2005-04-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-07-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37367
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) - Product Code CBI
  • Reason
    The distal end of the tube may be printed incorrectly, with catalog numbers v5-16037 and 5-16037 stating 'bronchial - right' instead of 'bronchial - left', and catalog number 5-16137 stating 'bronchial - left' instead of 'bronchial - right'.
  • Action
    Customers were notified via Federal Express, Next Business Day Delivery, on February 23, 2005. The accounts were informed of the mislabeling and were instructed to inspect the product lots for any incorrectly printed devices, comparing the writing on the sleeve of the blue bronchial tube with the package label which is correct, and to return all identified affected product to Teleflex Medical, Hudson RCI.

Device

Device Recall Hudson RCI/Novaplus Sheridan SherIBronch Left Endobronchial Tube
  • Model / Serial
    catalog number (REF) V5-16037, lot number 1145385;  catalog number (REF) 5-16037, lot numbers 1147855 and 1146242
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and internationally to Argentina, Canada, Chile, China, Costa Rica, Hong Kong, Korea, the Netherlands, South Africa and Vietnam.
  • Product Description
    Sheridan Sher-I-Bronch Left Endobronchial Tube; an Rx, sterile, sinlge use endobronchial tube with modified tip for left bronchial intubation, 37 Fr.; Hudson Respiratory Care Inc., Temecula, CA 92589-9020, Manufactured in Mexico; sold under the following catalog numbers: || a) catalog number (REF) V5-16037: Novaplus Sterile Sher-I-Bronch Endobronchial Tube for Left Bronchial Intubation, 37 Fr., Novation Corporation, Irving, TX 75062 || b) catalog number (REF) 5-16037: Hudson RCI Sheridan Sher-I-Bronch Endobronchial Tube for Left Bronchial Intubation, 37 Fr.
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical
  • Manufacturer Address
    Teleflex Medical, 2345 Waukegan Rd, Suite 120, Bannockburn IL 60015
  • Source
    USFDA