Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2018-RN-00474-1
Product Name/Description Earmoulds in use with children under 36 months

Model: EM2108

ARTG Number: 159614
Recall Action Level Retail
Recall Action Classification Class II
Recall Action Commencement Date 19/06/2018
Responsible Entity Starkey Laboratories Australia Pty Ltd
Reason/Issue 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.
Recall Action Product Defect Correction
Recall Action Instructions 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.

This action has been closed out on the 06/12/2018.
Contact Information 1800 024 985 - Starkey Hearing Technologies