Events

Recall of Various Sage Oral Care Products

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-2017-RN-01172-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-09-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01172-1
  • 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 medical australia has been advised by the manufacturer sage products llc that there is the potential for cross-contamination of specific oral care solutions manufactured by a third party supplier on equipment shared with non-pharmaceutical products. the affects all oral care products containing solutions manufactured by the third party supplier. the affected products were distributed between july 2015 and august 2017.
  • Action
    1. Discontinue use and/or further distribution of the affected lots. 2. Immediately quarantine any affected stock and complete the supplied acknowledgement form and email to austcs@teleflex.com 3. Destroy or dispose of affected product and provide records to Teleflex on the supplied acknowledgment form. 4. Complete the supplied recall acknowledgement form and return it to Teleflex. This form must be completed even if you no longer have affected product.

Device

Various Sage Oral Care Products

Manufacturer

Teleflex Medical Australia Pty Ltd