Events

Recall of Earmoulds in use with children under 36 months

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Starkey Laboratories 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-2018-RN-00474-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-06-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00474-1
  • 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
    Starkey have been made aware of a single incident in the uk where an unattended child aged 7 months has required treatment to remove an earmould from the larynx. this is the first reported incident of its kind, the likelihood of such event is considered extremely low and on this occasion there was no long-term injury.There have been no reported incidents in australia relating to this issue.
  • Action
    Starkey is recommending clinicians glue tubing in place for new mould orders manufactured for children up to the age of 36 months. Clinicians are advised to mark orders with "Glue-inTube" when patients meet this criterion.

Device

Earmoulds in use with children under 36 months

Manufacturer

Starkey Laboratories Australia Pty Ltd