Events

Recall of TOPPER Xtra Absorbent Dressing Pads, Sterile

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by KCI Medical 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-2014-RN-00893-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-08-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00893-1
  • 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, systagenix has become aware that the sterility of some product may be compromised due to small holes in the bottom layer of the primary pouch; its subsequent use may therefore pose a potential risk of localised infection.
  • Action
    Users are advised to discontinue use of affected stock and monitor any patients who are using, or have recently used, any of the affected products for signs of localised infection, including heat, pain, redness or swelling around the wound or increased wound drainage. If symptoms are presented then the clinician should treat appropriately. This action has been closed-out on 1/06/2016.

Device

TOPPER Xtra Absorbent Dressing Pads, Sterile
  • Model / Serial
    TOPPER Xtra Absorbent Dressing Pads, Sterile Product codes: P55263 and P55264 – all pack sizesAll lots affectedARTG number: 168750
  • Manufacturer
    KCI Medical Australia Pty Ltd

Manufacturer

KCI Medical Australia Pty Ltd