Events

Recall of Medline Procedure Packs containing ConvaTec Unomedical Brand Frazier Suction Handle

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-2016-RN-00971-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-07-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00971-1
  • 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
    Medline is issuing an instruction’s for use (ifu) for the convatec unomedical brand frazier suction handle. this action is being taken in response to complaints received by convatec in relation to breaking of the instrument at the junction of the handle and the metal tubing when pressure is applied at the tip. if the issue were to occur, it would result in a loss of suction and loss of visibility in the surgical field. there is a low risk of tissue damage or the potential for debris to remain in the surgical field as a result of the device breaking. there have been no injuries reported as a result of this issue.
  • Action
    The manufacturer has decided to issue an IFU to instruct the users on how to use the product appropriately to avoid any breakage of the instrument. Medline is providing hospitals with the IFU along with the customer letter. This action has been closed-out on 22/02/2017.

Device

Medline Procedure Packs containing ConvaTec Unomedical Brand Frazier Suction Handle
  • Model / Serial
    Medline Procedure Packs containing ConvaTec Unomedical Brand Frazier Suction HandleMultiple Product Codes and Procedure Packs affectedARTG Numbers: 137394, 137395, 136870, 140054, 140055, 140057, 140058, 140059, 140387, 161683, 161684, 161685
  • Manufacturer
    Medline International Two Australia Pty Ltd

Manufacturer

Medline International Two Australia Pty Ltd