Events

Safety Alert for Single Needle Bloodlines for AK Machines

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

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
    2014-03-18
  • Event Date Posted
    2014-03-18
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140318.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: gambro single needle bloodlines for ak machines the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning single needle bloodlines for ak machines, manufactured by gambro. the affected product codes (with batch numbers) are 114524 (batch number: from 1317 to 1350), 114561 (batch number: from 1316 to 1401) and 114527 (batch number: from 1316 to 1321) respectively. according to the manufacturer, there is a possible defect on the concerned products, involving a potential bonding of the venous male luer with the drain bag connector and/or of the arterial male luer with the spike connector. when the defect occurs, the cone of the luer may be damaged if the operator forces the disconnection of the bonded luer. performing a treatment with a damaged luer connection could result in an intake of air into the bloodline which could potentially reach the patient and would not pass through the “air in blood” protective system of the dialysis machine. the manufacturer advises users not to use the affected products, but, instead, use product from different lots or similar product as available. the affected product will be collected and replaced by the manufacturer. for details, please refer to the following link:http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con391268 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 18 march 2014.

Device

Single Needle Bloodlines for AK Machines
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Gambro Single Needle Bloodlines for AK Machines
  • Manufacturer
    Gambro

Manufacturer

Gambro