Events

Safety Alert for Horizons International TWISTER PLUS Rotatable Retrieval Device

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

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
    2013-11-22
  • Event Date Posted
    2013-11-22
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131122.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: horizons international twister plus rotatable retrieval device boston scientific, as the distributor of the twister plus rotatable retrieval device initiated a recall of the device in coordination with horizons international corporation which is the manufacturer of the device. the affected catalogue number, material number and lots/batches as follows: twister plus rotatable retrieval device - 22mm (box of 1) : catalogue number 6141, material number m00561410, lot/batch number h13061101, h13062403, h13062404, h13071301 twister plus rotatable retrieval device - 22mm (box of 5) : catalogue number 6141, material number m00561411, lot/batch number h13061101, h13062403, h13062404, h13071301 twister plus rotatable retrieval device - 22mm (box of 10): catalogue number 6141, material number m00561412, lot/batch number h13061101, h13062403, h13062404, h13071301 twister plus rotatable retrieval device - 26mm (box of 1): catalogue number 6142, material number m00561420, lot/batch number h13061102, h13061103, h13061104, h13062401, h13062402, h13071302, h13082603 twister plus rotatable retrieval device - 26mm (box of 5): catalogue number 6142, material number m00561421, lot/batch number h13061102, h13061103, h13061104, h13062401, h13082603 twister plus rotatable retrieval device - 26mm (box of 10): catalogue number 6142, material number m00561422, lot/batch number h13061102, h13061104, h13062401, h13062402, h13071302, h13082603 it has come to the attention of boston scientific that the packages of certain lots/batches of twister plus may not be fully sealed, affecting the sterility of the device. use of a retrieval device from a package with an open seal may impart a patient risk of infection. the manufacturer is advising customers to identify any product from the affected lots/batches within their inventory, segregate the affected product immediately and return it to boston scientific. according to the local supplier, the affected products were not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 22 november 2013.

Device

Horizons International TWISTER PLUS Rotatable Retrieval Device
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Horizons International TWISTER PLUS Rotatable Retrieval Device
  • Manufacturer
    Boston Scientific / Horizons

Manufacturer

Boston Scientific / Horizons