Events

Recall of Covidien Devon Light Glove (included in multiple Procedure Packs)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Medline International Two 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-00064-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-01-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00064-1
  • 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
    Customers have reported that on rare occasions, the devon light glove may split upon application to the devon light handle adapter. some of the reported splits resulted from difficult application of the light glove to the handle adapter. more recently, clinicians have reported finding splits in the light glove following surgery completion, where no difficulty in application of the light glove was encountered or finding splits directly out of the package. a split in the light glove causes a breach in the sterile field and can increase the potential for infection. there have been two reports in which splits were found at the conclusion of surgery.
  • Action
    Medline is advising users to remove and discard the Covidien Light Glove from the procedure pack at the time of surgery preparation.

Device

Covidien Devon Light Glove (included in multiple Procedure Packs)
  • Model / Serial
    Covidien Devon Light Glove (included in multiple Procedure Packs)Multiple Product Codes ARTG Number for the Light Glove itself: 186761ARTG Numbers for the affected Procedure Packs containing the Light Glove: 140059, 136870, 137395, 140054 and 140058
  • Manufacturer
    Medline International Two Australia Pty Ltd

Manufacturer

Medline International Two Australia Pty Ltd