Events

Safety Alert for Neonatal Endotracheal Tube SCP Clamp/Holders

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Capatex 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
    2012-05-25
  • Event Date Posted
    2012-05-25
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120525.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: capatex neonatal endotracheal tube scp clamp/holders the medicines and healthcare products regulatory agency (mhra), united kingdom issued a medical device alert concerning neonatal endotracheal tube scp clamp/holder manufactured by capatex medical. the manufacturer is recalling the products prior to batch 1002854. according to the mhra, a change was made to the composition of the plastic material used, to make the clamps/holder dehp-free. this affected the physical properties of the clamps, resulting in an increased risk of slippage. to counteract this, capatex added an extra notch on the clamp. however, this introduced the possibility of over-tightening and occlusion of the internal diameter of the endotracheal tube. as a result, there is a risk of airway loss due to slippage or airway obstruction. the manufacturer recommended that checks must be made to ensure the endotracheal tube is not slipping or being compressed. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/medicaldevicealerts/ index.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted 25 may 2012.

Device

Neonatal Endotracheal Tube SCP Clamp/Holders
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Capatex Neonatal Endotracheal Tube SCP Clamp/Holders
  • Manufacturer
    Capatex Medical

Manufacturer

Capatex Medical