Events

Recall of Device Recall Hudson RCI Tracheal Tubes

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
    70248
  • Event Risk Class
    Class 2
  • Event Number
    Z-1078-2015
  • Event Initiated Date
    2015-01-09
  • Event Date Posted
    2015-02-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-09-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132631
  • 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 (w/wo connector) - Product Code BTR
  • Reason
    Labeling; the affected product packaging is incorrectly labeled as being a cuffed oral et tube; the correct product labeling is uncuffed nasal et tube.
  • Action
    Teleflex Medical sent an " Urgent Medical Device Recall Notification" dated January 9, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. They were instructed to immediately discontinue use and quarantine any of the affected products, return the product and to complete the enclosed Recall Acknowledgement Form even if they do not have the affected product in stock. Distributors were instructed to communicate the recall to any of their customers who may have received product included within the scope of the recall. Have the customers return any affected product to them, together with a completed Recall Acknowledgement Form. Teleflex Medical is committed to providing high quality, safe and effective products. We sincerely apologize for any inconvenience this action may cause your operations. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.

Device

Device Recall Hudson RCI Tracheal Tubes
  • Model / Serial
    Catalog no. 5-22110, Lot no. 01M1300076.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Distribution to the states of FL, GA, IL, KY, MA, MI, MO, MS, OH, TX, WA and WV., and to the countries of Canada and the Netherlands.
  • Product Description
    Hudson RCI, Sheridan, Preformed Tracheal Tubes, Cuffed and Uncuffed, Rx Only, Sterile, Teleflex Medical.
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical
  • Manufacturer Address
    Teleflex Medical, 2917 Weck Dr, Research Triangle Park NC 27709-0186
  • Manufacturer Parent Company (2017)
    Teleflex Incorporated
  • Source
    USFDA