Events

Safety Alert for Flexi-Slip Endotracheal Tube Stylet with Soft Distal Tip and Flexislip Stylet, Sterile Pack

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Teleflex Medical.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2015-09-02
  • Event Date Posted
    2015-09-02
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150902b.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: teleflex flexi-slip endotracheal tube stylet with soft distal tip and flexislip stylet, sterile pack the medicines & healthcare products regulatory agency (mhra) has issued a medical device safety alert concerning flexi-slip endotracheal tube stylet with soft distal tip (product code: 502501) and flexislip stylet sterile pack (product codes: 503700-000060, 503700-06) manufactured by teleflex medical. the manufacturer has received reports of the plastic coating of the stylet splitting and/or breaking off of the stylet. this may result in a piece of plastic totally or partially occluding the patient’s airway and impairing ventilation, or necessitating invasive removal procedures in order to prevent complications such as atelectasis or pneumonia. according to the manufacturer, no patient injuries have been reported related to this issue. users are advised to quarantine and cease use of the affected products. for details, please refer to the tga website:https://mhra.Filecamp.Com/public/file/29qi-f3qkkkq2 if you are in possession of the affected products, please contact your supplier for necessary actions posted on 2 september 2015.

Device

Flexi-Slip Endotracheal Tube Stylet with Soft Distal Tip and Flexislip Stylet, Sterile Pack
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Teleflex Flexi-Slip Endotracheal Tube Stylet with Soft Distal Tip and Flexislip Stylet, Sterile Pack
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical