Recall of RUSCH CrystalClear Tracheostomy 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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • 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
    Tube tracheostomy and tube cuff - Product Code JOH
  • Reason
    Recalled due to air leakage from the main ventilation lumen through air passageway, resulting in potential injury requiring medical intervention.
  • Action
    Teleflex Medical sent an URGENT FIELD SAFETY NOTICE dated January 4, 2011, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their stock for product, cease use and distribution of stock from the affected lot number and quarantine all products from the affected lot number immediately. Customers were instructed to complete the field safety corrective action acknowledgement and stock status form and fax to their local Teleflex Medical Customer Service Sales Rep. If the customers did have stock from the affected lot number, they were to contact their local Teleflex Medical Customer Service/Sales Rep or distributor as indicated on the attached field safety corrective action acknowledgement and stock status form for a Return Autorization Number. Distributors were to communicate the field safety corrective action notice to their customers and forward the completed Acknoweldgement Form to or fax to +353 1 437 0773. For questions regarding this recall call +353 906 460 838


  • Model / Serial
    Catalog number: 121610 and 858510.
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Worldwide Distribution - Arabia, Asia, Austria, Belgium, Czech Republic, Denmark, Estonia, Germany, Greece, Ireland, Italy, Spain, Saudi Kuwait, Portugal, Russia Federation, Sweden, Slovenia and South America.
  • Product Description
    RUSCH CrystalClear Tracheostomy Tube, Cuffed, Sterile Pack || Crystal Clear Tracheostomy Tube is a device inserted into a patients trachea surgically via the neck to maintain an open airway.
  • Manufacturer


  • Manufacturer Address
    Teleflex Medical, 4024 Stirrup Creek Dr, Durham NC 27703-9000
  • Manufacturer Parent Company (2017)
  • Source