Events

Safety Alert for Katzen™ Infusion Wire

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

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
    2011-08-09
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20110809.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
    Field safety notice: boston scientific katzen™ infusion wire boston scientific has issued an urgent product recall of one lot/batch of katzen™ infusion wires (material no. (upn). m001461930; catalogue no. 46-193; lot/batch no. 14270326; expiry date march 2014) because the label on the carton and the inner pouch indicates an incorrect device length. according to the manufacturer, no injuries are expected to occur as a result of this mislabeling. if physician could not reach the target anatomic location because the device was shorter than expected, a minimal delay in the procedure would occur. boston scientific suggests immediately ceasing further distribution or using of any remaining products affected by this recall. recalled products will be replaced. according to the local supplier, hong kong is not affected. if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

Katzen™ Infusion Wire
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: [9 Aug 2011] Boston Scientific Katzen™ Infusion Wire
  • Manufacturer
    Boston Scientific

Manufacturer

Boston Scientific
  • Manufacturer Parent Company (2017)
    Boston Scientific
  • Manufacturer comment
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    DH