Events

Recall of Self-Righting Luer Slip Tip Cap, Yellow in the DISCPAC packaging

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Baxter Healthcare Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2015-RN-00113-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2015-03-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00113-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    Baxter healthcare identified that the affected products (self-righting luer slip and luer lock tip caps ) were manufactured and shipped with inaccurate single and case labels, missing the latex symbol. the heat shrink tape used on the discpac package is the only product component that contains latex. the instructions for use (ifu) correctly identifies the content of latex. unintended or accidental exposure to latex has the potential to elicit a hypersensitivity reaction, especially in sensitised individuals. symptoms may range from skin irritation to anaphylaxis. baxter has not received any reports of adverse events associated with this issue.
  • Action
    Baxter is alerting its customers of this labelling issue of missing latex symbol in an effort to prevent unintended exposure to latex. Baxter is updating the labelling of the affected products to include the latex symbol for future batches. This action has been closed-out on 02/03/2016.

Device

Self-Righting Luer Slip Tip Cap, Yellow in the DISCPAC packaging
  • Model / Serial
    Self-Righting Luer Slip Tip Cap, Yellow in the DISCPAC packagingProduct Code: H93866025All lot numbers with expiration date 10/2014 to 10/2017ARTG number: 217859
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd