Events

Recall of C-Qur, C-Qur TacShield and C-Qur V-Patch (used for tissue reinforcement during surgery)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Atrium Australia - Pacific Rim Pty Limited.

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-00751-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-07-26
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00751-1
  • 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
    Atrium medical has become aware that if the product is exposed to excessive humidity for an extended period of time, the increased humidity occurring inside the pouch can potentially cause the coating on the mesh to strongly adhere to the inner handling sleeve. this becomes evident if:- it becomes difficult to peel the mesh from the handling sleeve, or- the yellow coating material separating the mesh is retained on the clear plastic liner.
  • Action
    Atrium Medical is providing users with updated Instructions for Use (IFU) which include an additional warning and handling information to ensure the device is not used if the coating material separates from the mesh. The storage requirements have also been added to the product labels.

Device

C-Qur, C-Qur TacShield and C-Qur V-Patch (used for tissue reinforcement during surgery)
  • Model / Serial
    C-Qur, C-Qur TacShield and C-Qur V-Patch (used for tissue reinforcement during surgery)All lot numbers 10405513 and higherC-QurMultiple Catalogue Numbers affected ARTG Number: 163310C-Qur TacShieldCatalogue Numbers: 31610, 31611, 31612, 31626, 31628, 31633, 31636, 31637, 31638, 31644ARTG Number: 182852C-Qur V-PatchCatalogue Numbers: 31200, 31201, 31202ARTG Number: 174772
  • Manufacturer
    Atrium Australia - Pacific Rim Pty Limited

Manufacturer

Atrium Australia - Pacific Rim Pty Limited
  • Source
    DHTGA