Safety Alert for Multiload Radiopaque Cu375 intrauterine contraceptive devices

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Merck Sharp & Dohme (Asia) Limited.

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.

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  • Type of Event
    Safety alert
  • Date
  • Event Country
  • Event Source
  • Event Source URL
  • 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
    Press release
  • Reason
    Recall of multiload radiopaque cu375 intrauterine contraceptive devices (with photos) the department of health (dh) today (march 26) instructed a local medical device supplier, merck sharp & dohme (asia) limited to recall one lot of multiload radiopaque cu375 intrauterine contraceptive devices (iucds), manufactured by an irish company, multilan ag, following discovery of impurities inside the packing of a number of devices. the discovery was made by dh's family health service (fhs) when they conducted routine inspection of stock prior to distributing the devices for use by their maternal and child health centres (mchcs). among some 300 iucds inspected belonging to lot number sm-3337-13, 4 devices were found to contain tiny hair-like or dust-like impurities inside their sterile pouches. so far, mchcs have not used iucds from the affected lot. the fhs reported the issue to the supplier as well as the medical device control office, which began investigation immediately. according to the supplier, about 950 devices from the affected lot were distributed to public and private hospitals and some private clinics. the dh has not received any relevant report of adverse incidents in hong kong. as a precautionary measure, the supplier is instructed to conduct a batch recall of the product with lot number sm-3337-13 from the market. the supplier has set up a hotline (3971 2913) for enquiries. healthcare professionals should stop using the affected products immediately. dh has brought the matter to relevant stakeholders' attention and will follow up on the investigation. ends.


  • Model / Serial
  • Product Description
    Press release: Recall of Multiload Radiopaque Cu375 intrauterine contraceptive devices (with photos)
  • Manufacturer