Events

Recall of Receptal 1000 mL liner and canister used with the Laerdal Suction Unit

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Laerdal 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-2013-RN-00440-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-05-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00440-1
  • 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
    Laerdal has advised that the following situations can result in loss of suction:1. the hard canister and the single use liner are not properly seated;2. the liner separates from the canister during use.
  • Action
    Laerdal are requesting their customers to immediately seek an alternative to the 1000 mL Receptal system. Laerdal recommend to only discontinue use of the suction liners and canister once an alternative is sourced. Once an alternative has been sourced the 1000 mL Receptal liners and canister should be discarded.

Device

Receptal 1000 mL liner and canister used with the Laerdal Suction Unit
  • Model / Serial
    Receptal 1000 mL liner and canister used with the Laerdal Suction UnitItem code: 78001033ARTG Number: 129688
  • Manufacturer
    Laerdal Pty Ltd

Manufacturer

Laerdal Pty Ltd