Events

Recall of Various Terumo Introducer Kits Glide Shealth Slender Radifocus Introducer II (Femoral) Radifocus Introducer II M Coat (Transradial)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Terumo 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-00713-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-05-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00713-1
  • 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
    Terumo has identified an issue where a potential loss of package integrity may compromise the sterility of the introducer kits. an incomplete seal in the kit's peel pouch was observed during a routine internal inspection by terumo. terumo has not received any customer complaints or reported patient injuries as a result of this issue. the potential incidence rate is estimated to be less than 0.02%.
  • Action
    Terumo is advising users to quarantine and destroy all product from the affected lots. Terumo will provide credit for destroyed product within the affected lots.

Device

Various Terumo Introducer Kits Glide Shealth Slender Radifocus Introducer II (Femoral) Radifocus ...
  • Model / Serial
    Various Terumo Introducer Kits Glide Shealth SlenderRadifocus Introducer II (Femoral)Radifocus Introducer II M Coat (Transradial)Multiple Product Codes and Lot NumbersARTG Number: 126256
  • Manufacturer
    Terumo Australia Pty Ltd

Manufacturer

Terumo Australia Pty Ltd