Events

Safety Alert for Vented Paclitaxel Set

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Baxter 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
    2015-11-05
  • Event Date Posted
    2015-11-05
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20151105.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: baxter healthcare vented paclitaxel set medical device manufacturer, baxter healthcare has issued a medical device safety alert concerning vented paclitaxel set. the affected product code and lot numbers are as follows: product code (lot number): mmc9627s (14h13v434) product code (lot number): vmc9627 (14i05t696, 14k19t380, 15b17t404) the manufacturer is voluntarily issuing a recall for the above referenced lots due to complaints for leaks at the spike’s air vent subassembly. according to the manufacturer, a leak in a paclitaxel set may result in a breach in sterility of the fluid path with subsequent contamination of the solution. if the leak was not detected during priming or initial set up, it would lead to serious adverse health consequences. besides, the leak may result in skin contact that would lead to potential irritation of skin. the manufacturer is advising users to inspect and quarantine any affected stock for return to the manufacturer. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 5 november 2015.

Device

Vented Paclitaxel Set
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Baxter Healthcare Vented Paclitaxel Set
  • Manufacturer
    Baxter Healthcare

Manufacturer

Baxter Healthcare