Events

Recall of Hypochlorite 1% Solution & Hypochlor 1% Solution

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Dentalife 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-2015-RN-01222-2
  • Event Risk Class
    Class III
  • Event Initiated Date
    2015-12-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01222-2
  • 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
    It has come to dentalife's attention that there is a contamination risk in two batches of sodium hypochlorite solution small particles of black matter have been observed floating in several 1.25l bottles of the solution. the issue has been investigated and the material is suspected to be particles of a food grade grease used to lubricate the volumetric filling device as part of the manufacturing process.
  • Action
    Dentalife is advising users to discard affected stock for replacement. This action has been closed-out on 29/08/2016.

Device

Hypochlorite 1% Solution & Hypochlor 1% Solution
  • Model / Serial
    Hypochlorite 1% Solution & Hypochlor 1% SolutionProduct Codes: DL0403, HPH125 (1.25L) and DL0401 (500mL)Batch Numbers: 2356 and 4209Expiry Dates: 06/17 and 09/17ARTG Number: 160242
  • Manufacturer
    Dentalife Australia Pty Ltd

Manufacturer

Dentalife Australia Pty Ltd