Events

Recall of Restylane SubQ Lidocaine (Used for facial tissue augmentation)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Q-Med (Sweden) 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-2013-RN-00163-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-02-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00163-1
  • 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
    The manufacturer has identified a technical issue with the blister pack of the restylane subq lidocaine syringes during an internal quality control procedure. the defect affects the blister pack and therefore the external sterility of each syringe can no longer be guaranteed.
  • Action
    Customers are being requested to return all affected batches in the reply paid envelope provided with recall letter. Unaffected replacements will be provided upon receipt of the returned stock.

Device

Restylane SubQ Lidocaine (Used for facial tissue augmentation)
  • Model / Serial
    Restylane SubQ Lidocaine (Used for facial tissue augmentation)Lot numbers: 11907 and 11516Article numbers: 10-77001, 107702, 10-77005ARTG number: 193814
  • Manufacturer
    Q-Med (Sweden) Australia Pty Ltd

Manufacturer

Q-Med (Sweden) Australia Pty Ltd
  • Source
    DHTGA