Events

Recall of Super Arrow-Flex Percutaneous Sheath Introducer Set

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Teleflex 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-00113-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-01-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00113-1
  • 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
    The reason for this action is due to potential packaging damage where the outer packaging may exhibit scratches or pin holes. therefore, the sterility of the product cannot be guaranteed. if a non-sterile product is used, there is potential for infection to occur. no patient injuries have been reported related to this issue.
  • Action
    Teleflex is advising users to quarantine any affected stock for return to Teleflex. A credit note will be issued for stock returned. This action has been closed-out on 25/01/2017.

Device

Super Arrow-Flex Percutaneous Sheath Introducer Set
  • Model / Serial
    Super Arrow-Flex Percutaneous Sheath Introducer SetSAP/Catalogue Numbers: CL-07635, CL-07735 and CL-07835Multiple batch numbers affectedARTG Number: 135922
  • Manufacturer
    Teleflex Medical Australia Pty Ltd

Manufacturer

Teleflex Medical Australia Pty Ltd