Events

Recall of SURGICAL GOWN UL HP L (Molnlycke Health Care Pty Ltd - Gown, operating room, single use)

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-2017-RN-01433-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-11-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01433-1
  • 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 internal rigorous quality checking, mölnlycke has self-identified a quality issue with specific batches of gowns released between october 6th till october 16th 2017. the issue is regarding foreign particles (loose threads) being identified on the products.No complaints or reports of patient harm related to this issue have been received as of november 2017.
  • Action
    Customers are requested to; 1. Identify and isolate all affected, BARRIER Ultimate Surgical Gown at your facility; 2. Complete the confirmation form supplied with the customer letter and e-mail/fax back per its instructions. Even if you no longer have any concerned BARRIER Ultimate Surgical Gown, Mölnlycke needs to be sure all customers are aware of the situation; 3. Mölnlycke will contact you and arrange for collection of the product(s) from your facility, as soon as you return the confirmation form. Mölnlycke will organize to issue a credit for the goods returned; and 4. If you have forwarded any affected products to other healthcare institutions, send them a copy of the customer letter together and make sure they act accordingly.

Device

SURGICAL GOWN UL HP L (Molnlycke Health Care Pty Ltd - Gown, operating room, single use)
  • Model / Serial
    SURGICAL GOWN UL HP L (Molnlycke Health Care Pty Ltd - Gown, operating room, single use)Product number: 6901021-01Batch number: 17357759ARTG number: 138941
  • Manufacturer
    Molnlycke Health Care Pty Ltd

Manufacturer

Molnlycke Health Care Pty Ltd