Events

Recall of 300mL Canister (with Gel) for use with the ActiV.A.C. Therapy System

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-2015-RN-01169-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-12-02
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01169-1
  • 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
    Internal testing has revealed the potential for small holes the size of a pin to develop in the pouches of the sterile canisters. if these small holes occur and the canister is used in a sterile field, there is a potential for contamination.To date, there have been no complaints regarding damaged packaging or reports of any patient injuries or complications due to potentially non-sterile canisters.
  • Action
    The sponsor is advising the users to inspect stock and quarantine the affected units prior to their return. Alternatively, users can continue to use the affected devices provided that the tubing cap remains in the tubing until use and the canister is used outside of the operating room's sterile field. This action has been closed-out on 26/08/2016.

Device

300mL Canister (with Gel) for use with the ActiV.A.C. Therapy System
  • Model / Serial
    300mL Canister (with Gel) for use with the ActiV.A.C. Therapy System Part number M8275059/5Lot Numbers: 2590876 (expiry date 11/2016) and 2590877 (expiry date 01/2017) ARTG Number: 226774
  • Manufacturer
    KCI Medical Australia Pty Ltd

Manufacturer

KCI Medical Australia Pty Ltd