Events

Safety Alert for KFlow Epic Catheter Range

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

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
    2014-10-24
  • Event Date Posted
    2014-10-24
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20141024.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: kimal kflow epic catheter range medical device manufacturer, kimal, has issued a field safety notice concerning its kflow epic catheter range. the affected product codes (lot numbers) are kfe-hdl-1219-k (0013009), kfe-hdl-1435-pck (0013010), kfe-rsdl-1419-k (0013009), kfe-rsdl-1423-k (0013009), kfe-rsdl-1427-k (0013009), and kfe-rhdl-1423.K (0013009). the above kflow epic products may have a discrepancy with the seal of the breather bags. there may be some cases where the breather bag has failed to seal, meaning the product is no longer sterile. the manufacturer asks users to inspect stock of the above mentioned products and lot numbers. should they identify that the breather bag is not sealed, users should discontinue use, isolate, label and quarantine any stock to prevent continued use. product replacement can be arranged. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 24 october 2014.

Device

KFlow Epic Catheter Range
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Kimal KFlow Epic Catheter Range
  • Manufacturer
    Kimal

Manufacturer

Kimal