Events

Recall of Various Safeset and Transpac Blood Pressure Transducer Sets

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-2017-RN-01237-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-10-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01237-1
  • 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 identified a potential for detachment or separation of pressure tubing/luer bonded connections on specific blood pressure tranducer sets. icu medical has received reports due to this issue and there is the potential for serious injury. as a precaution, icu medical is recalling the affected devices.
  • Action
    ICU Medical is advising users to inspect stock and quarantine all affected units. Any remaining affected stock will be returned and replaced or a credit note issued.

Device

Various Safeset and Transpac Blood Pressure Transducer Sets
  • Model / Serial
    Various Safeset and Transpac Blood Pressure Transducer SetsMultiple Products, Item and Lot Numbers affectedARTG Number: 195624
  • Manufacturer
    ICU Medical Australia Pty Ltd

Manufacturer

ICU Medical Australia Pty Ltd
  • Source
    DHTGA