| TGA Action ID |
RC-2026-RN-00239-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
The M Zn-Air Battery Pak for use with the Naida CI M and Sky CI M Sound Processors
Product Code: CI-5501
Multiple Batch Numbers
Manufactured before February 3, 2026. |
| ARTG Number |
404765 |
| Action Type |
Product Correction |
| Action Level |
Consumer |
| Hazard Classification |
Class II |
| Reason for the Action |
The M Zn-Air Battery Pak packaged configuration includes a battery cartridge, tamperproof battery door, and non-tamperproof battery door.
The non-tamperproof battery door does not require the use of a tool to replace the button batteries and therefore could allow unintended access to the button cell batteries within the battery compartment. Button cell batteries and other small parts may be swallowed, breathed into the airway, or inserted into the nose or ears.
The tamperproof battery door requires a tool for removal and may continue to be used normally.
This action has been undertaken prior to notification to the TGA. |
| Instructions for Customers/Users |
Customers are to:
- Inspect their device and identify the non-tamperproof door.
- Remove and dispose of the non-tamperproof door.
- Install the tamperproof door.
- Contact Advanced Bionics if they require a replacement tamperproof door.
If ingestion or insertion of a button battery is suspected, seek immediate medical attention.
For further information on identifying the non-tamperproof door, please refer to the customer letter. |
| Action Commencement Date |
20/04/2026 |
| Responsible Entity |
|
| Contact Information |
02 8858 1600 - Advanced Bionics |