Events

Safety Alert for Portex Low Dead Space Connector with Sideport

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

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
    2014-06-13
  • Event Date Posted
    2014-06-13
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140613.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: smiths medical portex low dead space connector with sideport the united states food and drug administration (fda) has issued a medical device safety alert concerning portex low dead space connector with sideport [product reorder no.: 10035-05ps; lot no.: 2553426], manufactured by smiths medical asd, inc. the affected products were distributed in november 2013. one lot of 3.0mm sized connectors, product reorder no. 10035-05ps, lot 2553426 were placed in packages labeled as 3.5mm. affected users are advised to examine their inventory and remove all affected products. for details, please refer to the following fda website:http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm400982.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 13 june 2014.

Device

Portex Low Dead Space Connector with Sideport

Manufacturer

Smiths Medical ASD