Events

Recall of TISSUE-GUARD Family of Products - VASCU-GUARD, DURA-GUARD, PERI-GUARD and SUPPLE PERI GUARD (Xenograft)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Baxter Healthcare 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-01036-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-10-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01036-1
  • 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
    There is a possibility of packaging leakage for the tissue-guard family of products- vascu-guard, dura-guard, peri-guard, and supple peri-guard. these products are packaged in a container filled with sterile, non-pyrogenic water containing propylene oxide. the contents of the unopened, undamaged container are sterile. leakage can occur as a result of damage during shipment and can be identified by an unsealed container or by highly visible evidence of water damage to the packaging, instructions for use, box, label, and/or - surrounding products in the shipping container.
  • Action
    Baxter is requesting their customers to locate all affected product and return for credit.

Device

TISSUE-GUARD Family of Products - VASCU-GUARD, DURA-GUARD, PERI-GUARD and SUPPLE PERI GUARD (Xeno...
  • Model / Serial
    TISSUE-GUARD Family of Products - VASCU-GUARD, DURA-GUARD, PERI-GUARD and SUPPLE PERI GUARD (Xenograft)
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd