Events

Recall of Medline Custom Procedure Kits Class 2b

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
    21017
  • Event Initiated Date
    2017-01-17
  • 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
    It has been 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, when removing glove from packaging.
  • Action
    Instructions for use to be updated

Device

Medline Custom Procedure Kits Class 2b
  • Model / Serial
    Model: , Affected: CS1672744, CS1672725, CS1672725, CS1672725, CS1671553, CS1672725, CS1672725, CS1672750, CS1671552
  • Manufacturer
    Medline Assembly Australia Pty Ltd

Manufacturer

Medline Assembly Australia Pty Ltd