| TGA Action ID |
RC-2026-RN-00311-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Aural Ventilation Tubes (Grommets)
Model Number: E106
Lot Number: 12210 |
| ARTG Number |
133977 |
| Unique Device Identifier (UDI) |
Refer to Device FSN Document in Supporting Information |
| Action Type |
Recall / Product Alert |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
CR Kennedy & Company Pty Ltd is the supplier of Exmoor Plastics Ltd products in Australia. Exmoor recently changed its steam sterilisation supplier for PTFE grommets. It was discovered that a small number (approximately 0.1% - 0.5%) of Aural Ventilation tubes had a compromised sterile barrier integrity. Sterility assurance could not be confirmed with 100% certainty. This resulted in the potential for compromised sterile barrier integrity which may result in the product being non-sterile at the time of use.
To date, no patient harm has been reported due to this problem. |
| Instructions for Customers/Users |
Customers are to:
· Identify affected batch and quarantine immediately to prevent further use.
· Complete the Customer Response Form below and return it to rsmith@crkennedy.com.au to organise a refund/replacement.
· Do not remove any devices that are already implanted in patients.
· Patients implanted with affected devices should continue to be monitored in accordance with standard clinical practice.
This action has been closed out on 07/07/2026 |
| Action Commencement Date |
29/04/2026 |
| Responsible Entity |
|
| Contact Information |
0419 330 118 - CR Kennedy & Co |