Recall of Sheridan T.T.X. Tracheal Tube Exchanger, Large Size

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
  • Event ID
  • Event Risk Class
    Class 3
  • Event Number
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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
    Tracheal Tube exchanger - Product Code LNZ
  • Reason
    Biological indicator failed. investigation eliminated all equipment and product related factors.
  • Action
    Teleflex Medical sent Urgent Medical Device Recall letters dated 9/27/06 via UPS overnight to the direct accounts, informing them that the product did not pass validated sterility test requirements, and requesting that they cease use of the affected units and return them to Teleflex Medical for replacement. If the accounts further distributed the product, they were requested to conduct a sub-recall of the affected units from their customers. The accounts were instructed to complete and return by fax the enclosed Acknowledgement & Stock Status Form, indicating the number of units being returned for replacement. Any questions were directed to Linda Todd at 1-800-334-9751, ext. 4951.


  • Model / Serial
    catalog number (REF) 5-24006, lot number 1189037
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Nationwide and Argentina, Canada, Chile, Japan, Malaysia, the Netherlands and New Zealand
  • Product Description
    Sheridan T.T.X. Tracheal Tube Exchanger, Large Size for tracheal tube sizes 7.5 mm - 10.0 mm; a Rx, sterile, single use tracheal tube exchanger; Hudson Respiratory Care Inc., Temecula, CA 92589-9020, Manufactured in Mexico; catalog number (REF) 5-24006
  • Manufacturer


  • Manufacturer Address
    Teleflex Medical, 2345 Waukegan Rd Ste 120, Bannockburn IL 60015-1580
  • Source