Events

Recall of Nv Guider Catheter 90cm NV GUIDER CATHETER 90CM 40° 7F; NV GUIDER CATHETER 90CM ST 7F; NV GUIDER CATHETER 90CM ST 8F

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-2017-RN-01517-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-12-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01517-1
  • 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
    Stryker has initiated a lot specific product recall on certain lots of guider 7f and 8f product which may be at risk of degrading within their shelf-life period. the root cause of the issue is exposure of components to uv light while in storage between 2014 and october 2017.There have been no reports of injuries associated with this issue.
  • Action
    Stryker is advising users to inspect stock an quarantine any remaining units of the affected product. Affected stock can be returned to Stryker and replaced with unaffected product.

Device

Nv Guider Catheter 90cm NV GUIDER CATHETER 90CM 40° 7F; NV GUIDER CATHETER 90CM ST 7F; NV GUIDER ...
  • Model / Serial
    Nv Guider Catheter 90cm NV GUIDER CATHETER 90CM 40° 7FItem Number: 10043 Lot Numbers: 19948645, 18836128, 19545073, 19793264, 19809517, 20024281 NV GUIDER CATHETER 90CM ST 7FItem Number: 10051 Lot Numbers: 18898135, 18898416NV GUIDER CATHETER 90CM ST 8F Item Number: 10052 Lot Numbers: 18643117ARTG Number: 146034
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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