Events

Safety Alert for Sterile Disposable Vaginal Speculums

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Taizhou Kangjian Medical Equipment Co..

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
    2016-05-18
  • Event Date Posted
    2016-05-18
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160518.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: sterile disposable vaginal speculums manufactured by taizhou kangjian medical equipment co., ltd it has come to the attention of the medical device control office that several maternal and child health centres of the department of health have reported incidents relating to disposable vaginal speculums manufactured by taizhou kangjian medical equipment co., ltd. the incidents involved breakage of the handles and/or blades of the speculums, dislodgement of screwing rods and presence of black debris inside the packages. the affected vaginal speculums are identified as follows: cusco style, sterile, 105 mm (length) x 22 mm (width), model number ta3201, lot number 20150320 cusco style, sterile, 130 mm (length) x 28 mm (width), model number ta3203, lot number 20150320 the issues have been reported to the local supplier, tin ho enterprises co. ltd. and investigation is underway. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 18 may 2016.

Device

Sterile Disposable Vaginal Speculums
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Sterile Disposable Vaginal Speculums Manufactured by Taizhou Kangjian Medical Equipment Co., Ltd
  • Manufacturer
    Taizhou Kangjian Medical Equipment Co.

Manufacturer

Taizhou Kangjian Medical Equipment Co.