Events

Recall of Brennen Skin Graft Mesher - 4.5 and 6.5 inch

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-00536-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-05-01
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00536-1
  • 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
    Resulting from a post-market internal investigation, mölnlycke has identified a potential safety issue regarding the current sterilisation validation for the brennen skin graft mesher. with the current sterilisation instructions contained in the instructions for use (ifu), the sterility of the mesher cannot be guaranteed following a sterilisation cycle carried out according to those instructions. given the sterility of the brennen skin graft mesher cannot be guaranteed there is a risk for possible contamination, which may lead to infection. mölnlycke confirms that no product, patient or user complaints have been reported to date for products in australia regarding this issue.
  • Action
    Mölnlycke is advising users to immediately stop using the Brennen Skin Graft Mesher and apply the tag (i.e. label) provided by Mölnlycke to the device, or otherwise remove the device from service using applicable labelling and/or quarantine measures under the respective in house quality management system. The tag supplied states that the device is out of service and should not be used. Once the new sterilisation parameters have been confirmed by the manufacturer, through further validation testing during May, Mölnlycke will send users the updated IFU defining the new Sterilisation Procedure. This is estimated to occur in June 2017.

Device

Brennen Skin Graft Mesher - 4.5 and 6.5 inch
  • Model / Serial
    Brennen Skin Graft Mesher - 4.5 and 6.5 inchProduct Codes: 131500, 131501, 131502, 131503, 131504, 131506, 131600, 131601, 131602, 131603, 131604All Lot NumbersARTG Number: 196830
  • Manufacturer
    Molnlycke Health Care Pty Ltd

Manufacturer

Molnlycke Health Care Pty Ltd