Safety Alert for Suction Catheter w/Funnel

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

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
    2018-07-05
  • Event Date Posted
    2018-07-05
  • Event Country
  • Event Source
    DH
  • Event Source URL
  • 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: convatec, suction catheter w/funnel medical device manufacturer, convatec, has issued a medical device safety alert concerning its suction catheter w/funnel [product code: icc 502463 (finished pack code 0504218); sap code: 1301774; lot number: 483380, 486850, 493166, 495586, 177896, 176040, 191182, 6l01511, 6l06635, 7b05120, 7b06425, 7f06072, 7l03168, 8d01193]. the manufacturer has voluntarily initiated a global recall of the affected products. testing conducted on the medical device confirmed the potential for a sterile product becoming non-sterile. the affected users are advised to quarantine all affected lots. product recall is on-going. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on5 july 2018.

Device

  • Model / Serial
  • Product Description
    Medical Device Safety Alert: ConvaTec, Suction Catheter w/Funnel
  • Manufacturer

Manufacturer