Events

Safety Alert for Drytec Tc-99m Generator Lot number 5666

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

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
    2009-04-23
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/press_20080502.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
    Press release
  • Reason
    Voluntary recall of device containing non-sterile radioactive material the department of health (dh) received notification from a medical device manufacturing company about its voluntary recall of a batch of radiodiagnostic device which has failed the sterility test. according to the company- uk ge healthcare, the involved batch was known as drytec tc-99m generator lot number 5666. there was a possibility of infection if the non-sterile product was injected into patients. the device is used to prepare radioactive material for injection to patients during radiodiagnostic procedures. information available showed that the affected lot had been used in tuen mun hospital and hong kong sanatorium and hospital. so far, no adverse effect associated with the use of device has been received by dh. the dh has informed the hospital authority, private hospitals, radiodiagnostic laboratories and medical professional associations about the recall and advised them to check for details with the company. dh will continue to monitor the situation and advise the public and health profession accordingly. ends/wednesday, april 23, 2008.

Device

Drytec Tc-99m Generator Lot number 5666
  • Model / Serial
  • Product Description
    Press release: Voluntary recall of device containing non-sterile radioactive material
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare