Events

Safety Alert for Dual Luer Lock Caps

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

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
    2013-09-23
  • Event Date Posted
    2013-09-23
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130923.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 dual luer lock caps the u.S. food and drug administration (fda) have posted a press release issued by baxter concerning its dual luer lock caps with the followings: product code: 2c6250 lot number: 10043 and 10044 affected lots were distributed to customers between 19 jun 2013 and 20 aug 2013. there is the presence of loose particulate matter found in the packaging of the affected products. particulate matter entering the fluid path from the luer lock caps may result in thrombotic and embolic events, including pulmonary embolism, myocardial infarction and stroke. there have been no reported complaints associated with this issue. according to the manufacturer, customers should not use product from the two recalled lots and should locate and remove all affected product from their facility. affected lots should be returned to baxter. according to the local supplier, the affected products were not distributed in hong kong. for details, please refer to fda website http://www.Fda.Gov/safety/recalls/ucm369253.Htm if you are in possession of the product, please contact your supplier for necessary actions. posted on 23 september 2013.

Device

Dual Luer Lock Caps
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Baxter Dual Luer Lock Caps
  • Manufacturer
    Baxter

Manufacturer

Baxter