Events

Recall of Transpac Monitoring Kits Arterial Safeset Transpac IT w/3 ml Reservoir and Single CSP, With Velcro Arm Strap, Patient Mount; Arterial Transpac IT Monitoring Kit w/Safeset Reservoir, 03 ml Flush Device and 2 CSP

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-2014-RN-00877-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-08-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00877-1
  • 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
    Icu medical has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak. a leaking luer may have the potential effect of blood leakage or air embolism which may be life threatening or cause permanent severe injury or illness to the patient. there have been no reports of patient injury due to this problem.
  • Action
    ICU Medical Australia Pty Ltd is requesting their customers to inspect their stocks and quarantine all units from the affected lots. This action has been closed-out on 03/06/2016.

Device

Transpac Monitoring Kits Arterial Safeset Transpac IT w/3 ml Reservoir and Single CSP, With Velcr...
  • Model / Serial
    Transpac Monitoring KitsArterial Safeset Transpac IT w/3 ml Reservoir and Single CSP, With Velcro Arm Strap, Patient Mount Item Number: 011-46104-42Lot Numbers: 2841944, 2841945, 2859326, 2865873 & 2869445Arterial Transpac IT Monitoring Kit w/Safeset Reservoir, 03 ml Flush Device and 2 CSP Item Number: 011-46106-72Lot Numbers: 2841690, 2841691 & 2859331ARTG Number: 206780
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    ICU Medical Australia Pty Ltd

Manufacturer

ICU Medical Australia Pty Ltd
  • Source
    DHTGA