Events

Recall of ARROW OnControl System Trays ARROW OnControl Bone Lesion Biopsy System Tray ARROW OnControl Bone Marrow Biopsy System Tray ARROW OnControl System Sterile Procedure Tray

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-01494-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-11-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01494-1
  • 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
    Teleflex has identified an issue where there is the potential for an incomplete seal on the outer sterile package. because of the compromised packaging, the sterility of the inside drape, which is used in preparation for bone marrow aspiration with the oncontrol system, cannot be guaranteed. if sterility of the drape is compromised, there is the potential for infection to occur.
  • Action
    Customers are advised not to use or further distribute any affected stock. Teleflex Medical will arrange collection of the stock under quarantine and a credit to be applied to the customer's account.

Device

ARROW OnControl System Trays ARROW OnControl Bone Lesion Biopsy System Tray ARROW OnControl Bone ...
  • Model / Serial
    ARROW OnControl System TraysARROW OnControl Bone Lesion Biopsy System TrayARROW OnControl Bone Marrow Biopsy System TrayARROW OnControl System Sterile Procedure TrayCatalogue Numbers: 9403-EU-006, 9408-EU-006, 9411-EU-006, 9462-EU-001, 9463-EU-001, 9464-EU-001, 9466-EU-001Multiple Batch NumbersARTG Number: 264374
  • Manufacturer
    Teleflex Medical Australia Pty Ltd

Manufacturer

Teleflex Medical Australia Pty Ltd