| TGA Action ID |
RC-2025-RN-00437-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Odontopaste OP8G
Batch Numbers: B3066, B3066F, B3066H
Product Code: OP8G
Expiry Date: Mar2026 |
| ARTG Number |
148898 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
Products were stored outside of the defined parameters of 5-25ºC. A short-term allowance of up to 2 weeks at temperatures up to 40ºC is supported by validation studies.
There is a risk that the efficacy of the device could be negatively impacted and/or unintended breakdown products could be formed.
However, no customer complaints, injuries, or adverse events related to this problem have been reported. |
| Instructions for Customers/Users |
Customers are to:
1.Immediately identify all affected lot numbers and quarantine them on-site to prevent further use.
2.Await collection arrangements, as the sponsor will coordinate the retrieval of all affected products.
3.Expect re-supply of replacement items from the distributor for all affected material that are returned.
This action has been finalised on 23/9/2025. |
| Action Commencement Date |
5/05/2025 |
| Responsible Entity |
|
| Contact Information |
07 3878 1901 - Alex Athanassiadis |