Events

Recall of Thoracentesis/paracentesis kit,Illinois needle aspiration,Jamshidi needle bone marrow

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by CareFusion Australia 316 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-2017-RN-00350-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-03-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00350-1
  • 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
    The manufacturer has received six reports where an open seal of the immediate packaging of devices was identified by customers. this open seal has the potential to compromise the sterility of the device(s). to date, no reports have been received in australia.The packaging for the affected product codes were found to have an opening in the seal which maintains the sterility of the device. the issue of the packaging failure is visually obvious.
  • Action
    Customers are advised to discontinue use of the identified codes for the affected lot numbers. Contact BD to return and if required arrange a replacement or credit.

Device

Thoracentesis/paracentesis kit,Illinois needle aspiration,Jamshidi needle bone marrow
  • Model / Serial
    Thoracentesis/paracentesis kit,Illinois needle aspiration,Jamshidi needle bone marrow Thoracentesis/paracentesis kit 10/CS - TPK1001 Lot No. (LN): 0000851185, 0000840336, 0000842215, 0000837811Illinois (TJ) needle aspiration - TIN3015, TIN3018LN: 0000841213, 0000848061, 0000841215, 0000841212, 0000852078Jamshidi (TJ) needle bone marrow - TJM4011, TJC6011, TJC3513, TJC4011 LN: 0000852932, 0000843076, 0000853878, 0000841124, 0000851431, 0000850937 ARTG: 120894, 120890, 120892
  • Manufacturer
    CareFusion Australia 316 Pty Ltd

Manufacturer

CareFusion Australia 316 Pty Ltd