Events

Recall of ReNew Reusable Tips (Scissors, Graspers and Dissectors)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by C R Kennedy & Co 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-01152-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-09-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01152-1
  • 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
    Microline surgical has received customer reports that the heat-shrink insulation tube of renew reusable scissor, grasper and dissector tips may split during autoclave sterilisation/re-sterilisation. if a split occurs, the heat-shrink could fall off during a surgical procedure and if cautery is needed, there is a potential for burn due to insulation failure.This issue is due to a malfunction related to the heat-shrink insulation tube that is located immediately proximal to the metal tip.
  • Action
    1. Users are to complete and return the supplied response form to the sponsor, even if the affected goods are no longer in possession. 2. A CR Kennedy Representative will contact customers to: a. Provide directions to initiate an RMA (Returned Material Authorisation) for the return of the ReNew Reusable tips at your facility. b. Discuss the availability of ReNew Disposable Tips that are counterparts to the Reusable items (where applicable). c. Organise a credit for all product returns to customer accounts.

Device

ReNew Reusable Tips (Scissors, Graspers and Dissectors)
  • Model / Serial
    ReNew Reusable Tips (Scissors, Graspers and Dissectors)All Product CodesARTG Number 192108
  • Manufacturer
    C R Kennedy & Co Pty Ltd

Manufacturer

C R Kennedy & Co Pty Ltd