Events

Safety Alert for BURETROL Solution Set with 150ml INTERLINK Burette

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
    2014-07-25
  • Event Date Posted
    2014-07-25
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140725.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 buretrol solution set with 150ml interlink burette medical device manufacturer, baxter healthcare, has issued a field safety notice (fsn) concerning its buretrol solution set with 150ml interlink burette. the affected product code is 2c7564 with the lot numbers dr13e06019, dr13j24021, dr13j24039 and dr13l11016. the affected products were distributed to customers between 14 march 2014 and 30 june 2014. according to the manufacturer, the voluntary recall was issued due to complaints of separation between the burette chamber and the drip chamber. the root cause for this issue has been identified and resolved. if the separation is not detected before connection with the administration set, there is a risk of contamination of the sterile fluid path which could lead to blood stream infection or sepsis and may be life-threatening. additionally, air may be aspirated into the vascular system, causing venous air embolism, which while is improbable may be life-threatening. there have been no adverse events reported for this issue. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 25 july 2014.

Device

BURETROL Solution Set with 150ml INTERLINK Burette
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Baxter BURETROL Solution Set with 150ml INTERLINK Burette
  • Manufacturer
    Baxter Healthcare

Manufacturer

Baxter Healthcare