Events

Recall of Medline procedure packs containing Unomedical Suction Tubing (Sterile and Non-sterile)

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-2015-RN-00606-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-07-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00606-1
  • 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
    An internal assessment of convatec’s product complaints has confirmed that these devices are not meeting their expectations or those of our customers. specifically, the connector part for application to the suction devices in these lots, has failed to meet its required reliability. suction tubes are intended to connect a suction device, such as a suction catheter or suction handle, to a vacuum unit. suction tubes are equipped with multi-purpose connectors that are designed to fit many suction devices and outlets. the connector parts of the specified lots have a higher probability to crack once applied to suction devices outlets.
  • Action
    Medline is requesting end users to remove and discard the Unomedical Suction Tubing from the procedure pack at the time the scrub nurse prepares for the surgery. This action has been closed-out on 15/08/2016.

Device

Medline procedure packs containing Unomedical Suction Tubing (Sterile and Non-sterile)
  • Model / Serial
    Medline procedure packs containing Unomedical Suction Tubing (Sterile and Non-sterile) Sterile Codes: 530.25.200, 530.25.300, 530.25.450, 530.25.600, 530.25.800, 530.30.200, 530.30.300, 530.30.450, 530.30.600, 533.30.300Non-sterile Codes: 533.25.050, 533.25.100, 533.25.150, 533.25.200, 533.25.300, 533.25.450, 533.25.600Multiple BatchesARTG Numbers: 137961 (Sterile) & 204281 (Non-sterile)
  • Manufacturer
    Medline International Two Australia Pty Ltd

Manufacturer

Medline International Two Australia Pty Ltd