Events

Safety Alert for Uromatic Tur Administration 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
    2016-01-14
  • Event Date Posted
    2016-01-14
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160114.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 uromatic tur administration set medical device manufacturer, baxter healthcare has issued a medical device safety alert concerning uromatic tur administration set. [product code: emc4015n; lot numbers: 14i01v842m, 14j30v283 and 14k03v521] the manufacturer has issued a recall for the above referenced lots due to complaints received related to the disconnection of the spike from the tubing of the set. according to the manufacturer, the most likely hazard resulting from this issue is delay / interruption of therapy. however, disconnections also have the potential to lead to microbial contamination of the fluid path and hence contamination of the surgical field. the manufacturer has not received any reports of adverse event or patient injury related to this issue. according to the local supplier, the affected products are distributed in hong kong. product recall in ongoing. if you are in possession of the products, please contact your supplier for necessary actions. posted on 14 january 2016.

Device

Uromatic Tur Administration Set
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Baxter Healthcare Uromatic Tur Administration Set
  • Manufacturer
    Baxter Healthcare

Manufacturer

Baxter Healthcare