Events

Recall of Pine O Cleen DisinfectantHospital Grade 1.25 Plastic Bottles

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Reckitt Benckiser 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-2018-RN-00207-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-03-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00207-1
  • 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
    Pine o cleen disinfectant hospital grade (artg: 60110) in 1.25l plastic bottles may have a sub visible stress crack in the bottle neck which may cause the bottle to leak or the cap to break off at the neck and spillage may occur. in the event this happens it will typically occur when the bottle is opened for the first time or within the first few uses.The health risk associated with this issue is accidental exposure to skin and eyes potentially causing transient irritation that would likely be self limiting.If there is contact with the eyes or skin, wash the area with a large amount of water. if irritation persists see your doctor.This recall does not affect any other batches or sizes of pine o cleen disinfectant or any other rb products. this batch has been distributed to retail trade from january 16th 2018 until february 24th, 2018.All product received post february 24th, 2018 is not affected.
  • Action
    Customers are asked to inspect their stock on hand and return affected product as per the instructions given in the Customer Letter

Device

Pine O Cleen DisinfectantHospital Grade 1.25 Plastic Bottles
  • Model / Serial
    Pine O Cleen DisinfectantHospital Grade 1.25 Plastic BottlesARTG Number: 60110(RECKITT BENCKISER NON-STERILE DISINFECTANTS, WITHOUT CLAIMS 'BENZALKONIUM CHLORIDE')
  • Manufacturer
    Reckitt Benckiser Pty Ltd

Manufacturer

Reckitt Benckiser Pty Ltd