Events

Recall of Surecan Angled Needle (Non-coring needle for access ports)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by B Braun Australia 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-2012-RN-01018-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-10-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01018-1
  • 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
    This recall action is being taken as a result of a potential defect detected in the packaging of the batches produced in june 2012. this packaging defect could compromise the sealing integrity of the single unit packaging and therefore the product sterility.
  • Action
    Quarantine and return affected stock to B. Braun.

Device

Surecan Angled Needle (Non-coring needle for access ports)
  • Model / Serial
    Surecan Angled Needle (Non-coring needle for access ports)Article code: 4439830Batch number: 2F2425A681ARTG Number: 133684
  • Manufacturer
    B Braun Australia Pty Ltd

Manufacturer

B Braun Australia Pty Ltd