Events

Recall of KIMVENT Closed Suction Systems (Tube, tracheal, general-purpose, single-use)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Kimberly Clark Aust 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-00827-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-09-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00827-1
  • 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
    There is a potential that the thumb valve of a very small percentage of kimvent closed suction systems can remain partially open after suctioning was completed, even though the valve appeared to be closed or in the “locked” position. this situation can result in a partial air leak from the ventilator circuit triggering the ventilator alarm and replacement of the closed-suction device.
  • Action
    Halyard Health is providing work around instructions to assist end users correct valve leaks caused by this issue. Halyard Health is undertaking an investigation to prevent this issue from occurring. This action has been closed-out on 18/08/2016.

Device

KIMVENT Closed Suction Systems (Tube, tracheal, general-purpose, single-use)
  • Model / Serial
    KIMVENT Closed Suction Systems (Tube, tracheal, general-purpose, single-use)KimVent Closed Suction System - Neonates/Paediatrics, 5F, 6F and 8F Y Adpater5F Lot #: M5067T05 & M5076T4026F Lot #: M5054T5128F Lot #: M5089T503 & M5082T502KimVent Closed Suction System - Adults, 14F, DSELot #: M5085T604KimVent Turbo-Cleaning Closed Suction System - Adults, 12F, DSE Lot #: M5096T306KimVent Turbo-Cleaning Closed Suction System - Adults, 14F, DSELot #: M5080T301ARTG: 129684
  • Manufacturer
    Kimberly Clark Aust Pty Ltd

Manufacturer

Kimberly Clark Aust Pty Ltd