Events

Recall of Basin Liner within Molnlycke ProcedurePak (surgical procedure packs)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Molnlycke Health Care 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-01042-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-10-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01042-1
  • 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
    During standard quality checking of components for use within molnycke health care procedurepak it has been found that some units of the basin liners provided in the pack have small holes in them which could be undetectable in normal use.
  • Action
    Molnlycke Health Care is requesting their customers to remove the affected basin liner from the pack once the pack is opened for surgery. A sterile bowl should be used in place of the liner.

Device

Basin Liner within Molnlycke ProcedurePak (surgical procedure packs)
  • Model / Serial
    Basin Liner within Molnlycke ProcedurePak (surgical procedure packs)ARTG entries: 133559, 133562, 133564, 133565
  • Manufacturer
    Molnlycke Health Care Pty Ltd

Manufacturer

Molnlycke Health Care Pty Ltd