Events

Recall of 4F Stiffened Micro-Introducer Kits (guidewire or catheter introducer) Product Description: STF 4F M.I. KIT 45CM NT/T ECHO S PG

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Medical Specialties 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-01295-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-10-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01295-1
  • 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
    Angiodynamics, inc., the manufacturer of the 4f stiffened micro-introducer kits, has become aware of the potential with respect to the 4f sheath/dilator components for the rotating luer to detach from the dilator hub during use.Use of the affected angiodynamics stiffened micro-introducer kits may result in patient harm, including minor tissue trauma and/or minor delay in procedure to replace the device.
  • Action
    Medical Specialties Australia have contacted affected customers and retrieved all unused product. This action has been closed-out on 24/05/2017.

Device

4F Stiffened Micro-Introducer Kits (guidewire or catheter introducer) Product Description: STF 4F...
  • Model / Serial
    4F Stiffened Micro-Introducer Kits (guidewire or catheter introducer)Product Description: STF 4F M.I. KIT 45CM NT/T ECHO S PGCatalogue Number: 06597052Lot Numbers: 5031722 & 5043440ARTG Number: 172522
  • Manufacturer
    Medical Specialties Australia Pty Ltd

Manufacturer

Medical Specialties Australia Pty Ltd
  • Source
    DHTGA