Events

Recall of Sage Comfort impregnated cloth topical skin products(impregnated with barrier creams and/or antiseptic agents & are used to protect &/or clean areas of skin)

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-01128-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-09-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01128-1
  • 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 recall was initiated due to product contamination of a few lots of comfort shield barrier cream cloths with the bacteria, burkholderia cepacia, that were manufactured on two production lines. although the contamination has not been identified in any other products, all products manufactured on the same production lines in the relevant period have also been recalled.Topical administration of a product with presence of microbial contamination may cause serious infections in immunocompromised persons and in hospitalised patients, as well as certain other patient groups.
  • Action
    Teleflex Medical is advising users to inspect stock and quarantine any remaining units of the affected product. Stock can be returned to Teleflex or place of purchase for a credit, refund or replacement. For more details, please see https://www.tga.gov.au/alert/comfort-impregnated-cloth-topical-skin-products . This action has been closed-out on 28/06/2017.

Device

Sage Comfort impregnated cloth topical skin products(impregnated with barrier creams and/or antis...
  • Model / Serial
    Sage Comfort impregnated cloth topical skin products(impregnated with barrier creams and/or antiseptic agents & are used to protect &/or clean areas of skin)Catalogue Numbers: 7453, 7526, 7905, 7413, 7988, 9601, 9602Various batch numbers affected (see attached)ARTG Number: 227609
  • Manufacturer
    Teleflex Medical Australia Pty Ltd

Manufacturer

Teleflex Medical Australia Pty Ltd