Events

Recall of T4 Zipper Toga (XL - Tall) (Operating room gown)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Stryker 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-00422-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-05-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00422-1
  • 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
    Testing by stryker indicated that the sterilisation barriers were not valid for the stated 3 year shelf life and a breach of sterilisation risk is present for products older than 2 years.
  • Action
    Stryker is asking customers to perform inspection of product expiry dates and lot numbers and discard any affected products.

Device

T4 Zipper Toga (XL - Tall) (Operating room gown)
  • Model / Serial
    T4 Zipper Toga (XL - Tall) (Operating room gown)Catalogue number: 0400850000Lot numbers: Lots prior to 12040356ARTG number: 141174
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    DHTGA