Events

Recall of Medline Custom Procedure Kits

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Medline Assembly 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
    18514
  • Event Initiated Date
    2015-05-14
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: REM Systems Limited, 69 Elizabeth Knox Place, Glen Innes, AUCKLAND
  • Reason
    Medline is recalling certain lots of procedure packs which contain covidien devon light gloves. 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, micro-organisms from the light handle could be transferred to the clinician and thus patient, resulting in risk of surgical site infection. medline is recommending that a light cover is discarded at the time of the surgical procedure.
  • Action
    Manufacturer to issue advice regarding use

Device

Medline Custom Procedure Kits

Manufacturer

Medline Assembly Australia Pty Ltd