Events

Safety Alert for Arrow Edge Hemodialysis Catherization Set Long-Term Access, Arrow NextStep Antegrade Hemodialysis Catheterization Set, Long-Term Access

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

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
    2014-02-11
  • Event Date Posted
    2014-02-11
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140211c.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: arrow international arrow edge hemodialysis catherization set long-term access, arrow nextstep antegrade hemodialysis catheterization set, long-term access the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning arrow edge hemodialysis catherization set long-term access, and arrow nextstep antegrade hemodialysis catheterization set, long-term access hemodialysis catheters, manufactured by arrow international, inc. the manufacturer has issued a voluntary recall for some lots of the hemodialysis catheter product codes due to receipt of complaints that the tunneling sheath packaged within the kits can crack during placement. if the tunneling sheath cracks, it can cause a delay in treatment for the time it takes to retrieve a replacement kit. the manufacturer advises users to cease use and distribution of stock of affected product and quarantine immediately. according to the local supplier, cemma enterprise, the devices were not distributed in hong kong. for details, please refer to the following link:http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con371783 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 11 february 2014.

Device

Arrow Edge Hemodialysis Catherization Set Long-Term Access, Arrow NextStep Antegrade Hemodialysis...
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Arrow International Arrow Edge Hemodialysis Catherization Set Long-Term Access, Arrow NextStep Antegrade Hemodialysis Catheterization Set, Long-Term Access
  • Manufacturer
    Arrow International

Manufacturer

Arrow International