Events

Recall of Disposable StrykeFlow Tip(electrosurgical suction tip)

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-2015-RN-00484-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-06-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00484-1
  • 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
    An internal review concluded that 6 lots of disposable strykeflow tips were shipped with a potentially deformed blister pouch, which could potentially impact the sterility of the product. although to date there have been no reported events of infection to stryker as a result of using potentially affected product, there is a remote possibility for infection due to usage of a non-sterile product.
  • Action
    Customers are asked to check any affected items in their possession and quarantine any affected units immediately. A Stryker Representative will coordinate an inspection of the affected items in quarantine. Any affected items will be removed by the Stryker Representative. This action has been closed-out on 2/06/2016.

Device

Disposable StrykeFlow Tip(electrosurgical suction tip)
  • Model / Serial
    Disposable StrykeFlow Tip(electrosurgical suction tip)Item Number: 250-070-505Affected Lots: 14021FG2, 13337FG2, 13343FG2, 13347FG2, 14007FG2, 14016FG2ARTG Number: 142786
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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