Events

Recall of Atrium Chest DrainsOcean Drains

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Maquet 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-2016-RN-01580-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-12-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01580-1
  • 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
    Atrium chest drainage products are packaged with a double sequential sterile wrap and placed into an outer dust cover. the dust cover is folded over and secured with the package label. the label on the outer package denotes the product as being sterile. the chest drain inside the packaging is sterile; the outer dust cover is not sterile. the two sterilisation wraps are what provide the sterile barrier for the product. this packaging system is the same configuration used on atrium chest drainage products for the past 30 years. maquet is providing users with clarification as to which part of the packaged drain is sterile. in addition, maquet is advising that product manufactured after october 18 2016 will contain a new warning label that identifies the pouch as not being a sterile barrier and warns the user that only the chest drain can be entered into the sterile field.
  • Action
    Maquet is informing users of the following steps for introduction of the Atrium Chest Drains into the sterile field; To introduce the chest drain into the sterile field: 1. Remove the wrapped chest drain from the dust cover. 2. Open the 2 sterilisation wraps using sterile technique. 3. Only enter the chest drain into the sterile field. Maquet is also providing the new warning label that product manufactured from October 18 2016 will contain, and is requesting users to post copies of this label near all Atrium chest drain product inventory with expiration date prior to October 2019. This action has been closed-out on 26/05/2017.

Device

Atrium Chest DrainsOcean Drains
  • Model / Serial
    Atrium Chest DrainsOcean DrainsModel Numbers: 2002-300, 2012-320, 2050-300Oasis DrainsModel Numbers: 3600-100, 3612-100, 3612-100, 3620-100Express DrainsModel Numbers: 4000-100N, 40120-100NExpress MiniModel Number: 16400All Lot Numbers with Expiration Date Prior to October 2019ARTG Number: 119726
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

Maquet Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    DHTGA