Events

Recall of Actifuse ABX and Actifuse MIS System

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-00774-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-08-25
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00774-1
  • 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 is issuing a recall of actifuse abx and actifuse mis system products with expiry before 29 july 2017 due to the possibility that the products may have endotoxin levels above specification criteria. in surgical procedures where there is device contact with the cerebrospinal fluid through a dural opening (iatrogenic injury), the use of a medical device with increased endotoxin levels may augment the typical inflammatory reaction to surgery and contribute to adverse health consequences. baxter has not received product-related adverse event reports that can be linked to cerebrospinal fluid exposure to increased levels of endotoxins.
  • Action
    Users are asked to inspect their stock and to remove affected product from their facility and to contact Baxter Customer service to arrange replacements. This action has been closed-out on 05/09/2016.

Device

Actifuse ABX and Actifuse MIS System
  • Model / Serial
    Actifuse ABX and Actifuse MIS SystemProduct Codes: 506005078047 Actifuse ABX, 1-2 mm, 2.5 mL506005078048 Actifuse ABX, 1-2 mm, 5.0 mL506005078049 Actifuse ABX, 1-2 mm, 10.0 mL506005078057 Actifuse ABX, 1-2 mm, 20.0 mL,506005078059 Actifuse ABX, 1-2 mm, 1.5 mL506005078069 Actifuse MIS System, 1-2 mm, 7.5 mL506005078071 Actifuse MIS System Refill, 1-2 mm, 7.5 mLLot Numbers: ALLARTG Numbers: 188736 & 193684
  • Product Classification
    Orthopedic Devices
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd