Events

Safety Alert for Neonatal and Paediatric Endotracheal Tube Clamp/Holder

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by EMS 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
    2012-07-25
  • Event Date Posted
    2012-07-25
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120725.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: ems medical neonatal and paediatric endotracheal tube clamp/holder the medicines and healthcare products regulatory agency (mhra), united kingdom issued a medical device safety alert concerning all neonatal and paediatric endotracheal tube clamp/holder manufactured by ems medical. according the mhra, the composition of the plastic used to make the clamp/holder was changed to a dehp-free material. this affected the physical properties of these components, resulting in an increased risk of slippage or tube obstruction. based on the information provided by the mhra, ems medical has gone into administration before this issue was identified and it is not known how many affected devices have been supplied. 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 on 25 july 2012.

Device

Neonatal and Paediatric Endotracheal Tube Clamp/Holder
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: EMS Medical Neonatal and Paediatric Endotracheal Tube Clamp/Holder
  • Manufacturer
    EMS Medical

Manufacturer

EMS Medical
  • Source
    DH