Events

Recall of Fenwal Transfer Pack 150ml with spike coupler (Blood collection/cell-culture container)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Aurora BioScience 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-01290-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-02-01
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01290-1
  • 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
    Instruction for use (ifu) manual for fenwal transfer packs 150ml with spike coupler is updated to instruct the users of the proper technique to insert/remove the coupler in order to access the bag. additionally a statement advising users that a suitable filter (170-200 microns) should be used when administering/transfusing blood products from this bag will also be added to the ifu.
  • Action
    Aurora Bio Science is arranging for recovery of affected stock, which is to be rectified with correct Instructions for Use (IFU). Replacement stock or a credit note is to be issued for the recovered stock.

Device

Fenwal Transfer Pack 150ml with spike coupler (Blood collection/cell-culture container)
  • Model / Serial
    Fenwal Transfer Pack 150ml with spike coupler (Blood collection/cell-culture container)Catalogue / Order number: R4R2001All batch numbersARTG Number: 169160
  • Manufacturer
    Aurora BioScience Pty Ltd

Manufacturer

Aurora BioScience Pty Ltd