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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