Events

Safety Alert for Sterile Water for Irrigation 1000ml

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

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
    2012-08-20
  • Event Date Posted
    2012-08-20
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120820.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 sterile water for irrigation 1000ml the medicines and healthcare products regulatory agency (mhra), united kingdom issued a medical device alert concerning sterile water for irrigation 1000ml manufactured by baxter healthcare ltd. the affected product code is ukf7114, lot no 12d10b26. this lot was supplied by baxter from 1 may 2012 to 22 may 2012 inclusive. there is a risk of contamination of this batch as there has been a report in france that bottles within this batch were contaminated with aspergillus. this case is still under investigation and the affected batch is being independently tested. meanwhile, customers are advised to quarantine bottles in the affected batch and liaise with baxter regarding availability of supplies and for updates. the mhra is liaising with baxter and will provide further updates as necessary. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/medicaldevicealerts /index.Htm if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 20 august 2012.

Device

Sterile Water for Irrigation 1000ml
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Baxter Sterile Water for Irrigation 1000ml
  • Manufacturer
    Baxter Healthcare Ltd

Manufacturer

Baxter Healthcare Ltd