Events

Recall of Blood Pressure Monitoring Kits with Transpac IV Transducers

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by ICU Medical 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-01335-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-10-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01335-1
  • 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
    It has been identified that there is a potential for leaks with certain monitoring kits that contain the transpac iv transducers. a small number of these devices may have the potential to leak or introduce small amounts of air into the line. in a worst case, there is potential patient harm due to air embolism or contamination. icu medical, inc. has not received any reports of adverse events associated with this issue.
  • Action
    ICU Medical is advising customers to arrange for their stock to be recovered and replacement stock, or a credit note to be issued. This action has been closed-out on 24/05/2017.

Device

Blood Pressure Monitoring Kits with Transpac IV Transducers
  • Model / Serial
    Blood Pressure Monitoring Kits with Transpac IV TransducersKit - Royal Women Hospital QLD, Special Care Nursery (Item: 011-0J069-01, Lot: 3253136)Kit - Neonatal/Childrens Australia (Item: 011-46103-16, Lot: 3263780)Safeset Transpac IV (Item: 011-46103-25, Lot: 3207778)Transpac IV (Item: 011-46104-49, Lot: 3242280)Single Line Monitoring Kit w/Transpac IV (Item: 011-46104-52, Lot: 3253165)Single Line Transpac IV Monitoring Kit (Item: 011-46107-16, Lot: 3235355)ARTG Number: 195624
  • Manufacturer
    ICU Medical Australia Pty Ltd

Manufacturer

ICU Medical Australia Pty Ltd
  • Source
    DHTGA