Events

Recall of Medline Procedure Packs containing Covidien Devon Light Gloves

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-2015-RN-00395-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-05-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00395-1
  • 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
    This recall has been initiated from the advice of medline’s supplier medtronic, involving lot numbers 508xxxx and below. these light gloves may contain splits and pin holes. if a clinician touches the handle unaware that the light glove is split and or contains pin holes, microorganisms from the light handle could be transferred to the clinician and thus patient, resulting in risk of surgical site infection.
  • Action
    Medline is advising end users to remove the Light Glove from the procedure pack and discard at the point of surgery. This action has been closed-out on 16/02/2016.

Device

Medline Procedure Packs containing Covidien Devon Light Gloves

Manufacturer

Medline International Two Australia Pty Ltd