| TGA Action ID |
RC-2025-RN-00438-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Odontocide OC8
Batch Number: B6008
Product Code: OC8
Expiry Date: Dec2025 |
| ARTG Number |
198289 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
It has been reported that during the period of December 2024 through to March 2025 the temperature within the distributor’s storage location exceeded the recommended storage temperature maximum of 25ºC for periods greater than 2 weeks.
Due to environmental conditions not being maintained between 5-25ºC, the potential exists of loss of product efficacy and/or product degradation. There is allowance for up to 2 weeks exposure to temperatures up to 40ºC.
Based on product design and usage, there is very little likelihood of serious or fatal impacts to patient health. A loss of product efficacy and/or product degradation may however cause temporary discomfort.
The worst likely outcome would be patient discomfort indicating a return visit to the healthcare specialist for a review, and potential re-application of the treatment.
There have been no customer complaints, and no injuries or adverse event related to this problem reported |
| Instructions for Customers/Users |
Customers are to quarantine affected stock immediately to prevent further use.
The sponsor will arrange for the collection of all affected product.
The distributor will re-supply replacement items for affected product that is returned.
This action has been finalised on 23/9/2025. |
| Action Commencement Date |
2/05/2025 |
| Responsible Entity |
|
| Contact Information |
07 3878 1901 - Alex Athanassiadis |