Events

Safety Alert for 15L Cycler Drainage Bag

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
    2013-11-06
  • Event Date Posted
    2013-11-06
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131106a.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 15l cycler drainage bag the australia therapeutic goods administration (tga) has issued a medical device safety alert concerning 15l cycler drainage bag manufactured by baxter healthcare. the affected product code is r5c4145p. baxter has identified an issue with the roberts clamp (large clamp on the drainage bag) that is used to close the drain tube on the 15l cycler drainage bag. the large clamp may not fully close the 15l cycler drainage bag drain tube after filling and may result in leakage from the drain tube. the manufacturer is advising users of the potential issue with the clamps and to take extra care to ensure the clamp on the drain tube is closed. according to the local supplier, the affected products were not distributed in hong kong. for details, please visit the following tga website: http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-01096-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 6 november 2013.

Device

15L Cycler Drainage Bag
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Baxter 15L Cycler Drainage Bag
  • Manufacturer
    Baxter Healthcare

Manufacturer

Baxter Healthcare