Events

Recall of Multigate Custom Procedure Packs containing Convatec’s Unomedical brand Suction Tube

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Multigate Medical Products 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-00601-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-07-02
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00601-1
  • 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
    Convatec is conducting a recall (tga ref no: rc-2015-rn-00514-1) of various sized unomedical branded suction tubes. the tubes are being recalled as the connector on the tubes has a probability of cracking once it is applied to suction device ports.Multigate is issuing this notice to your hospital as you have received the above custom procedure packs (cpp) where you have specified the inclusion of the unomedical suction tube that is now subject to this recall.
  • Action
    Multigate requesting end users to stop using the affected CPP. Multigate will supply replacement sterile tubing as for all the affected stock. Once replacement tubing is received end users are required to replace the defective tube with the sterile replacement product.

Device

Multigate Custom Procedure Packs containing Convatec’s Unomedical brand Suction Tube

Manufacturer

Multigate Medical Products Pty Ltd